The Commissioning, Qualification, and Validation (CQV) Engineer reports 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.
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The CQV Engineer performs commissioning, qualification, and validation testing on manufacturing process equipment and instruments, authors protocols, initiates controlled documentation, and provides client support for CQV projects either independently or as part of a larger team. 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 extensive interaction with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements. CQV Engineers 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 Integrity, Accountability, Unified Team (Teamwork), and Creativity (Innovation).
- Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under the Sr CQV Specialist's, CQV Engineer II's or Senior CQV Engineer's direct or indirect supervision
- Authors protocols
- Initiates controlled documentation in support of CQV projects as part of a team
- Develops documents such as master plans, design qualification, equipment, facility and utility commissioning and final reports under the Sr CQV Specialist's, CQV Engineer II's or Senior CQV Engineer's direct or indirect supervision
- Interacts with clients to identify CQV needs and work toward solutions that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices under direct or indirect supervision from the Sr CQV Specialist, CQV Engineer II or Sr CQV Engineer
- Follows project planning, management adn execution schedules
- Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use
- Investigates failures and deviations; creates reports
- Analyses and reviews of spare parts lists to ensure they are fit for purpose
- Reviews engineering drawings for accuracy and acts to correct errors under direct or indirect supervision of the CQV Engineer or Sr. CQV Engineer
- Performs system walk-downs and makes changes using the change control of processes
- Assists with Corrective and Preventative Actions (CAPAs) and makes recommendations to resolve deficiencies under supervision of the Sr CQV Specialist, CQV Engineer II or Sr CQV Engineer
- Creates summary and analyses reports
- Creates and maintains job plans, maintenance schedules and PMs under direct or indirect supervision of the Sr. CQV Specialist, CQV Engineer II or Sr. CQV Engineer
- Understands scope change and identifies scope change to supervisors for resolution
- Clear understanding of cGMPs and pharmaceutical and biopharmaceutical unit operations
- Understands and is able to apply principles of commissioning and qualification with an eagerness to learn
- Good analytical, organizational, time management and problem-solving skills. Can develop problem statements, identify root causes and create corrective actions to be executed within a prescribed timeline under direct or indirect supervision of the Sr CQV Specialist, CQV Engineer II or Sr CQV Engineer
- 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 Sr CQV Specialist, CQV Engineer II or Sr CQV Engineer
- Basic understanding of 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 and identify boundaries
- 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
- Detail oriented. Completes work tasks and documentation with minimal errors
- Ability to work independently or on a team
Experience & Education Required for CQV Engineer:
BS in Engineering, one year of relevant project experience and four years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System and Life Science manufacture industry experience is required.
MS in Engineering, one year of relevant project experience and two years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Quality System and 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 17025:2017. 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.