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Consultant - FCX/PCI - Raleigh, NC

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).   

 

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, age, disability, protected veteran status, marital status, medical condition or any other characteristic protected by law.


Nearest Major Market: Raleigh

Job Segment: Biotech, Engineer, Consulting, Pharmaceutical, Instrumentation, Science, Engineering, Technology