Senior CQV Engineer - FCX/PCI - Raleigh, NC
Raleigh, NC, US, 27617
9290-FCX Performance, Inc
The Commissioning, Qualification, and Validation Engineer/Senior Engineer 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 Engineer performs comm1ss1oning , 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 Honesty, Integrity, Pride, Accountability , Teamwork, and Commitment.
In addition to the above, Senior CQV Engineers initiate, develop, and lead CQV projects and teams (internal and at client sites) with both PCI and non-PCI team members. They are accountable for CQV project initiation, inception, design, development, implementation , management, follow up, and maintenance.
+ Performs commissioning , qualification, and validation testing on utilities and manufacturing process equipment and instruments
+ 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
+ Investigates failures and deviations; creates reports
+ Analyses and reviews spare parts lists to ensure they are fit for purpose
+ Reviews engineering drawings for accuracy and acts to correct errors
+ Performs system walk-downs and makes changes using the change control of processes
+ Initiates and resolves client Corrective and Preventative Actions (CAPAs)
+ Provides analyses and summary reports
+ Creates and maintains job plans, maintenance and PMs
Senior CQV Engineer (in addition to those listed above)
+ Independently initiates, establishes, provides direction, execution, and follow up of commissioning, qualification, calibration, and validation projects
+ Acts as a subject matter expert who provides high-level direction, strategic initiative and consistent follow-through on CQV projects
+ Interfaces and networks with industry professionals through professional organizations such as ISPE, PDA, NCSL, or ASQ. Shares SME knowledge through presentations, training sessions, or meetings
+ May implement controlled documentation systems in support of CQ projects
+ Expert understanding and work habits compliant with cGMPs and pharmaceutical and biopharmaceutical unit operations
+ Good understanding and application of commissioning and qualification and willingness to learn
+ Good analytical, organizational , time management and problem-solving skills
+ Exceptional 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 thorough understanding and knowledge to apply current industry guidelines and standards
+ Ability to read, interpret and correct P&IDs
+ A thorough and 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 in a corporate setting 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
+ Detail oriented with superior skills in planning, organizing, and communicating CQV project tasks across a multidisciplinary team
+ Ability to provide self-direction and work independently or on a team
Senior CQV Engineer
+ Subject-Matter-Expert (SME) with commissioning and qualification activities with a proven history of successful implementation of various manufacturing and utility, CIP and SIP systems, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, and equipment qualification, and use of the Validator 2000 or Kaye Digistrip
+ Proven leader with exceptional planning and organizing skills and a history of driving and delivering successful results
+ Excellent analytical, organizational, time management and problem-solving skills
+ Exceptional communication skills with ability to tailor messages for specific audiences such as director and above, operational and entry levels
+ Industry expert on regulatory issues and requirements with the ability to apply requirements to systems and processes to ensure compliance
Experience & Education Required for Senior CQV Engineer:
BS in Engineering, Life Sciences, or equivalent training with six years of relevant project experience, eight years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience. Subject-Matter Expert (SME) Quality System/Life Science manufacture industry experience is required. A current PE license is preferred.
MS in Engineering, four years of relevant project experience and six 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. A current PE license is preferred.
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.
AppliedÂ® 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.
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