Consultant

Location: 

Raleigh, NC, US, 27617

Company:  9290-FCX Performance, Inc

 

The PCI Consultants play pivotal roles in the organization by providing strategic client project initiatives, client proposal development and project oversight through specific, accurate, and detailed client proposals; realistic and achievable project timelines; along with budget and labor utilization awareness.  PCI Consultants also play a vital business development role in which their thorough understanding of client processes results in additional client solutions being provided by other PCI service teams.  Through networking, extensive communication, and an awareness of ongoing client activities, Consultants are expected to develop, grow, and expand business partner relationships with clients with an awareness of when client needs might change, expand, or develop into other PCI service arenas.

The PCI Consultants are exempt positions reporting to a Team Leader, Team Manager, Director, or Vice President, depending upon organizational structure.  Up to 100% travel may be required.
 

Expectations:

PCI Consultants are well respected Subject Matter Experts and called upon in the industry for their vast knowledge of key activities, processes and procedures and ability to share that knowledge in a professional way.  PCI Consultants also develop a true business partnership with all clients across various Life Science fields.  Consultants work closely with clients to research, identify, and provide effective long-term client solutions. They consistently uphold PCI Values and demonstrate Integrity, Accountability, Unified Team (Teamwork), and Creativity (Innovation).

 

In addition to the above, Senior Consultants lead teams (internal or external) with both PCI and non-PCI team members.  They are accountable for overall project initiation, planning, implementation, monitoring, controlling and closure while ensuring the project is delivered on schedule, within budget, within scope and to customer satisfaction. 


Expectations and Responsibilities:

Consultant

  • Understands project objectives, requirements, and assumptions necessary to structure a project or activity. Understands in-scope vs out-of-scope activities and communicates to project management for determination of need for scope change and additional funding requests.
  • Works independently or on a team.
  • Cultivates client relationships and builds trust through professionalism and expertise at the project level. Integrates into client environment in order to effectively execute projects while building positive professional relationships with clients and associates.  Proactively seeks to expand PCI services.  Identifies opportunities for new business and communicates these to management.
  • Possesses basic organizational skills.  Utilizes PCI Customer Account Folders to retain all project related documentation, plans, schedules, KPIs and reference documentation. 
  • Works closely with client project sponsors to research and identify efficiency gaps and compliance risks and provide effective long-term solutions.
  • Mentors new hires and develops associates by sharing experience and expertise. Seeks internal and external training to broaden personal breadth of experience and expertise.
  • Creates project-level Account Plans and develops a clear overview that includes the account service history, client goals; needs; objectives, site organizational structure, risks, escalation process and specific client guidance for project execution and deliverables with guidance from the Consultant II or Sr. Consultant.
  • Organizes and participates in Business Review Meetings that includes input from all PCI Service teams and highlights additional areas where PCI can add value to the client’s organization
  • Experienced with project safety requirements and ensures team members comply with industry, client and PCI site safety requirements
  • Actively participates in at least one professional organization (ISPE, PDA, NCSL, ASQ, etc.) to develop skills and maintain PCI's reputation as an industry leader by attending meetings, socials, technology shows and other active engagements.


Consultants will spend 80-100% of the time at the client facility.  In order to satisfy this requirement, up to 100% travel may be required.

 

Consultants implement and manage on-site Instrument Management Service contracts, as well as initiate, research, and provide project acquisition and development for new and existing clients.  Consultants will also manage PCI project teams, performing, supervising, and providing technical expertise with calibrations, instrument procurement, management of third-party services, resource scheduling, account management and maintaining PCI client account files in accordance with company procedures.

 

Consultant II

  • Define project objectives, requirements, and assumptions necessary to structure a project or activity and translate into scope documents/proposals.  Identifies out-of-scope activities and requests and acts on them through writing scope change documents and additional funding requests.
  • Leads teams and provides direction to others. 
  • Cultivates client relationships and builds trust through professionalism and expertise at the customer site level. Integrates into client environment in order to effectively lead projects while building positive professional relationships with clients and associates. Proactively seeks to expand PCI services.  Identifies opportunities for new business and communicates these to management.
  • Highly organized.  Sets up and utilizes PCI Customer Account Folders to retain all project related documentation, plans, schedules, KPIs and reference documentation.  Provides oversight and guidance to junior consultants to ensure PCI Account folders are utilized and maintained.
  • Works closely with client senior leadership to research and identify efficiency gaps and compliance risks and provide effective long-term solutions.
  • Mentors new hires and develops associates by delivering internal technical training programs to facilitate advancement and new skill sets among junior consultants. Seeks additional external training to broaden personal breadth of experience and expertise.
  • Creates customer-site-level Account Plans and develops a clear overview that includes the account service history, client goals; needs; objectives, site organizational structure, risks, escalation process and specific client guidance for project execution and deliverables independently or with minimal assistance
  • Develops and delivers Business Review Meetings that includes input from all PCI Service teams and highlights additional areas where PCI can add value to the client’s organization
  • Proactively assess project safety concerns and ensures team members comply with industry, client and PCI site safety requirements.
  • Networks with industry professionals.  Actively participates in at least one professional organization (ISPE, PDA, NCSL, ASQ, etc.) to develop skills and maintain PCI's reputation as an industry leader by attending meetings, socials, technology shows and other active engagements.


Senior Consultant

  • Acts as Account Manager.  Oversees multiple Project Leads and Project Managers.   Coordinates between multifunctional teams to obtain and assign resources and to develop schedules and activities to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. 
  • Defines project objectives, requirements, and assumptions necessary to structure a project or activity and translates them into scope documents or proposals.  Identifies out-of-scope activities and acts to document scope clarification and scope change documents.  Negotiates project changes and secures additional funding from the client prior to scope execution.  Reviews and approves scope change requests prior to submission to the client.
  • Oversees and manages multiple projects simultaneously
  • Cultivates client relationships and builds trust through professionalism and expertise at the Corporate level. Integrates into client and corporate environments in order to effectively lead projects with internal and external team members while building positive professional relationships with clients and associates. Proactively seeks to expand PCI services.  Proactively identifies opportunities for new business and translates them into clearly defined scopes of work to present to clients for approval and secure funding for proposed scopes.
  • Highly organized.  Sets up and utilizes PCI Customer Account Folders to retain all project related documentation, plans, schedules, KPIs and reference documentation.  Provides oversight and guidance to junior consultants to ensure PCI Account folders are utilized and maintained. Analyzes spend versus progress data to adjust resource loading to ensure project on-time delivery.
  • Works closely with client corporate global leadership to research and identify efficiency gaps and compliance risks and provide effective long-term solutions.
  • Subject Matter Expert.  Develops Life Sciences Industry related and technical training programs to present internally to consultants and externally to industry professionals in highly visible settings such as ISPE events.  Maintains a high level of proficiency by reading industry related periodicals and publications and participating on training and advisory boards of industry related organizations.
  • Creates corporate-level Account Plans and develops a clear overview that includes the account service history, client goals; needs; objectives, corporate organizational structure, risks, escalation process and specific client guidance for project execution and deliverables both globally and at each customer site.   Negotiates corporate-level service agreements such as Master Service Agreements.
  • Takes the lead to organize, develop and deliver Business Review Meetings that includes input from all PCI Service teams and includes high-level client personnel (Director level and above) and highlights additional areas where PCI can add value to the client’s organization.  Utilizes the BRM to learn about the client's initiatives, needs and future growth strategy and to develop PCI strategies to capitalize on additional business scope.
  • Performs Job Safety Analysis and proactively assess project safety concerns and ensures team members comply with industry, client and PCI site safety requirements.
  • Takes a leadership position in at least one professional organization (ISPE, PDA, NCSL, ASQ, etc.) to develop skills and maintain PCI's reputation as an industry leader by giving presentations, serving on committees, and other high-level functions within the organization. Drives engagement in the organization with junior team members.


Skills Required:

Consultant

  • Works directly with the Project Lead or Project Manager to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. 
  • Proficient with Microsoft Word, Excel, PowerPoint, Visio and Project
  • Communicates with clients with a high degree of technical understanding.
  • Analyzes business processes, diagnose inefficiencies, and conduct GAP analysis
  • Develops simple process flow diagrams.
  • Experience with System Impact and Component Level Criticality assessments
  • Understands Calibration and Maintenance programs and FDA requirements for both including developing range, tolerance and test point requirements, developing maintenance work plans, performing safety critical assessments and identifying spare parts program requirements
  • Familiar with Computer Validation System requirements and Computerized Maintenance and Calibration Management Systems (CMMS and CCMS) implementations
  • Good writing skills.  Able to develop SOPs, create final reports and author policies, procedures and guidelines under direct or indirect supervision.
  • Working knowledge of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes


Consultant II

  • Acts as Project Lead or Project Manager.   Assigns resources, schedules and activities to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. 
  • Highly skilled with Microsoft Word, Excel, PowerPoint, Visio and Project.  Can create formulas, change formatting and develop professional presentations to help monitor and control project execution and to develop project status reports.
  • Communicates with clients at a very high strategic level to build a foundation of trust, as well as have a thorough understanding of the specific details of the client processes.
  • Analyzes business processes, diagnose inefficiencies, and conduct GAP analysis. Proposes remedial action to correct issues uncovered in analysis.
  • Analyzes work flows and creates complex process flow diagrams.
  • Conducts System Impact and Component Level Criticality assessments. Recommends changes to clients to improve efficiency, reduce costs and reduce business risk.
  • Highly experienced with Calibration and Maintenance programs with an in-depth understanding of regulatory requirements.  Analyzes site-level process needs and develops range, tolerance and test point requirements, maintenance work plans, performs safety critical assessments and identifies spare parts program requirements
  • Proficient with Computer Validation System requirements.  Leads Computerized Maintenance and Calibration Management Systems (CMMS and CCMS) implementation projects.
  • Experienced writer.  Develops SOPs, creates final reports and authors quality policies, procedures and guidelines independently or with minimal assistance.  Reviews documents developed by junior members.  Ensures documents are accurate and compliant
  • In-depth understanding of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes.  Develops programs and procedures to comply with regulatory requirements.


Senior Consultant

  • Acts as Account Manager.  Oversees multiple Project Leads and Project Managers.   Coordinates between multifunctional teams to obtain and assign resources and to develop schedules and activities to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. 
  • Highly skilled with Microsoft Word, Excel, PowerPoint, Visio and Project.  Can create complex formulas, easily manipulate formatting and develop innovative professional presentations to help monitor and control project execution.  Develops project status reports to present to senior leaders and decision makers.
  • Communicates with clients (Director Level and above) at a very high strategic level to build a foundation of trust, as well as have a thorough understanding of the specific details of the client processes.
  • Analyzes business processes, diagnoses inefficiencies, and conducts GAP analysis.  Proposes remedial action to correct issues uncovered in analysis. Drives the adoption of high value systems to address system problems (i.e. CMMS, CCMS, paperless systems, etc.) and create connections between the customer and other PCI partners for global strategic initiatives.
  • Analyzes work flows from multiple sites to simplify process flow diagrams at a strategic global level across multiple client sites.
  • Subject Matter Expert.  Leads teams in conducting System Impact and Component Level Criticality assessments. Recommends changes to clients to improve efficiency, reduce costs and reduce business risk.
  • Expert understanding of Calibration and Maintenance programs and regulatory requirements.  Analyzes corporate processes to implement compliant global calibration and maintenance programs.
  • Expert level understanding of Computer Validation System requirements.  Works with clients to identify user requirement specifications and develops detailed project plans for Computerized Maintenance and Calibration Management Systems (CMMS and CCMS) implementations
  • Excellent writing skills.  Reviews and approves SOPs, final reports and quality policies, procedures and guidelines   Ensures documents are accurate and compliant before final approval
  • Subject Matter Expert of GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines.  Ensures compliance as they relate to qualification of systems and validation of processes.  Reviews and approves programs and procedures and makes recommendations to reduce regulatory compliance risk and make processes more efficient.


Experience & Education Required:

Consultant:  A four-year degree in Life Sciences, or other related technical field, or equivalent military training, and six or more years of instrumentation experience in the Life Sciences industry.  Familiarity with Quality Systems and the Life Science Manufacture Industry is required

The PCI Consultant, Consultant II and Senior Consultant play pivotal roles in the organization by providing strategic client project initiatives, client proposal development and project oversight through specific, accurate, and detailed client proposals; realistic and achievable project timelines; along with budget and labor utilization awareness.  PCI Consultants also play a vital business development role in which their thorough understanding of client processes results in additional client solutions being provided by other PCI service teams.  Through networking, extensive communication, and an awareness of ongoing client activities, Consultants are expected to develop, grow, and expand business partner relationships with clients with an awareness of when client needs might change, expand, or develop into other PCI service arenas.
 

The PCI Consultants are exempt positions reporting to a Team Leader, Team Manager, Director, or Vice President, depending upon organizational structure.  Up to 100% travel may be required.
 

Expectations:

PCI Consultants are well respected Subject Matter Experts and called upon in the industry for their vast knowledge of key activities, processes and procedures and ability to share that knowledge in a professional way.  PCI Consultants also develop a true business partnership with all clients across various Life Science fields.  Consultants work closely with clients to research, identify, and provide effective long-term client solutions. They consistently uphold PCI Values and demonstrate Integrity, Accountability, Unified Team (Teamwork), and Creativity (Innovation).   


Expectations and Responsibilities:

Consultant

  • Understands project objectives, requirements, and assumptions necessary to structure a project or activity. Understands in-scope vs out-of-scope activities and communicates to project management for determination of need for scope change and additional funding requests.
  • Works independently or on a team.
  • Cultivates client relationships and builds trust through professionalism and expertise at the project level. Integrates into client environment in order to effectively execute projects while building positive professional relationships with clients and associates.  Proactively seeks to expand PCI services.  Identifies opportunities for new business and communicates these to management.
  • Possesses basic organizational skills.  Utilizes PCI Customer Account Folders to retain all project related documentation, plans, schedules, KPIs and reference documentation. 
  • Works closely with client project sponsors to research and identify efficiency gaps and compliance risks and provide effective long-term solutions.
  • Mentors new hires and develops associates by sharing experience and expertise. Seeks internal and external training to broaden personal breadth of experience and expertise.
  • Creates project-level Account Plans and develops a clear overview that includes the account service history, client goals; needs; objectives, site organizational structure, risks, escalation process and specific client guidance for project execution and deliverables with guidance from the Consultant II or Sr. Consultant.
  • Organizes and participates in Business Review Meetings that includes input from all PCI Service teams and highlights additional areas where PCI can add value to the client’s organization
  • Experienced with project safety requirements and ensures team members comply with industry, client and PCI site safety requirements
  • Actively participates in at least one professional organization (ISPE, PDA, NCSL, ASQ, etc.) to develop skills and maintain PCI's reputation as an industry leader by attending meetings, socials, technology shows and other active engagements.


Consultants will spend 80-100% of the time at the client facility.  In order to satisfy this requirement, up to 100% travel may be required.
 

Consultants implement and manage on-site Instrument Management Service contracts, as well as initiate, research, and provide project acquisition and development for new and existing clients.  Consultants will also manage PCI project teams, performing, supervising, and providing technical expertise with calibrations, instrument procurement, management of third-party services, resource scheduling, account management and maintaining PCI client account files in accordance with company procedures.
 

Skills Required:

Consultant

  • Works directly with the Project Lead or Project Manager to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. 
  • Proficient with Microsoft Word, Excel, PowerPoint, Visio and Project
  • Communicates with clients with a high degree of technical understanding.
  • Analyzes business processes, diagnose inefficiencies, and conduct GAP analysis
  • Develops simple process flow diagrams.
  • Experience with System Impact and Component Level Criticality assessments
  • Understands Calibration and Maintenance programs and FDA requirements for both including developing range, tolerance and test point requirements, developing maintenance work plans, performing safety critical assessments and identifying spare parts program requirements
  • Familiar with Computer Validation System requirements and Computerized Maintenance and Calibration Management Systems (CMMS and CCMS) implementations
  • Good writing skills.  Able to develop SOPs, create final reports and author policies, procedures and guidelines under direct or indirect supervision.
  • Working knowledge of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processes


Experience & Education Required:

Consultant:  A four-year degree in Life Sciences, or other related technical field, or equivalent military training, and six or more years of instrumentation experience in the Life Sciences industry.  Familiarity with Quality Systems and the Life Science Manufacture Industry is required

PCI is proud to serve pharmaceutical, biotechnology, medical device, and clinical research industries nationwide by providing calibration, commissioning and consulting solutions.  At PCI, calibrations are performed by highly technical, cGMP/GLP-trained personnel who are knowledgeable in quality guidelines enforced by the FDA, EPA and ISO/IEC 17025:2017. PCI is an FCX Performance Company and a Subsidiary of Applied Industrial Technologies (NYSE: AIT); a leading industrial distributor that offers more than 6.5 million parts to serve the needs of MRO and OEM customers in virtually every industry.

Applied® provides engineering, design and systems integration for industrial and fluid power applications, as well as customized mechanical, fabricated rubber and fluid power shop services. Applied also offers storeroom services and inventory management solutions that provide added value to our customers.

We are an equal employment opportunity employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, ancestry, gender, sexual orientation, gender identity, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.


Nearest Major Market: Raleigh

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