The Commissioning, Qualification, and Validation Specialist I It report directly to the Team Leader, Manager. These positions are exempt. Up to 50% travel.
The CQV Specialist and CQV Specialist II performs commissioning, qualification, and validation testing on manufacturing process equipment and instruments, authors protocols, initiates controlled documentation and provides client support for CQV projects while under the direct or indirect supervision. Responsibilities may include generating 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 and CQV Specialist IIs take a proactive role in supporting CQV projects and in providing client support.
- Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under the Sr. CQV Specialist's, CQV Engineer's, CQV Engineer II's or Senior CQV Engineer's direct or indirect supervision
- Authors protocols
- Initiates controlled documentation and provides client support for CQV projects while under the CQV Specialist II's, Sr CQV Specialist's, CQV Engineer's, CQV Engineer II's or Senior CQV Engineer's direct or indirect supervision
- Assists in development of documents such as master plans, design qualification, equipment, facility and utility commissioning and final reports
- 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 failure and deviation investigations and reports
- Assists in development of spare parts lists to ensure they are fit for purpose. Assists in Identifying critical spare requirements and levels. Performs system walk-downs and follows the change control processes
- Performs system walk-downs and follows the change control processes
- Assists with investigations and implements approved client Corrective and Preventative Actions (CAPAs)
- Develops summary and analyses reports under direct or indirect supervision form CQV Specialist II, Sr CQV Specialist, CQV Engineer, CQV Engineer II or Sr CQV Engineer.
- Follows job plans to complete maintenance and PMs
- Follows project planning, management and execution schedules
- Understands scope change and identifies scope change to supervisors for resolution
- Good understanding of cGMPs and pharmaceutical and biopharmaceutical unit operations
- Basic understanding and application of commissioning and qualification and willingness to learn
- Good writing skills. Able to develop 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 under direct or indirect supervision of the CQV Specialist, Sr CQV Specialist, CQV Engineer II or Sr CQV Engineer
- Familiar with working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines, standards and safety requirements
- 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, PowerPoint, Visio and Project
- Hands-on experience working as a productive and supportive member of a project team
- Possesses 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, Ellab E-Val Pro or other validators and various temperature and relative humidity loggers
- Ability to 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. 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.