The Commissioning, Qualification, and Validation Specialist Specialist report directly to the Team Leader, Manager, or Director of the CQV Team, depending on the organizational structure. These positions are exempt. Up to 100% travel may be required.
The CQV Specialist performs commissioning, qualification, and validation testing on manufacturing process equipment and instruments; author protocols, initiate controlled documentation, and provide client support for CQV projects while under the CQV Engineer’s direct or indirect supervision. Responsibilities may include generation of documents such as master plans, design qualification, equipment, facility and utility commissioning and development and development of final reports. The position requires interaction with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements. CQV Specialists take a proactive role in supporting CQV projects and in providing client support. They build a high level of trust with internal and client personnel. This trust is developed through consistently upholding PCI Values and demonstrating Honesty, Integrity, Pride, Accountability, Teamwork, and Commitment.
- Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under the CQV Engineer’s or Senior CQV Engineer’s direct or indirect supervision
- Authors protocols, initiates controlled documentation in support of CQV projects
- Provides project planning, management, execution, and follow up
- Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
- Assists with failures and deviations investigations and reports
- Analyses and reviews spare parts lists to ensure they are fit for purpose
- Performs system walk-downs and follows the change control of processes
- Assists with investigations and implements approved client Corrective and Preventative Actions (CAPAs)
- Provides summary and analyses reports
- Follows job plans to complete maintenance and PMs
- Good understanding and work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations
- Basic understanding and application of commissioning and qualification and willingness to learn
- Good writing skills required to author and execute DQ, FAT, SAT, CTPIQ, OQ, PQ, and PV documents, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines.
- Be familiar with working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines and standards
- Ability to read and interpret P&IDs
- 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
- Proficient with Microsoft Word, Excel and Project
- Hands-on experience working as a productive and supportive member of a project team
- Validation experience in the following areas: manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification, and use of the Validator 2000 and/or Kaye Digistrip.
- Ability to provide self-direction and work independently or on a team
Experience & Education Required for CQV Specialist:
BS in Life Sciences, or equivalent training and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System/Life Science manufacture industry experience is required.
MS in Life Sciences or equivalent training and two years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System/Life Science manufacture industry experience 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 17025:2005. 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.