Consultant II

Location: 

Rockville, MD, US, 20850

Company:  9290-FCX Performance, Inc

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:

  • 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.

 

 

Skills Required:

  • 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.

 

Experience & Education Required:

A four-year degree in Life Sciences, or other related technical field, or equivalent military training, and eight or more years of instrumentation experience in the Life Sciences industry.  In-depth knowledge of Quality Systems and the Life Science manufacture industry and an understanding of regulatory requirements and ISPE Good Practices 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: Washington DC

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