Senior CQV Engineer (Pharma) (NC)
Date Posted: June 14, 2024
Job Description
We are seeking an experienced and highly proficient Senior Commissioning, Qualification, and Validation (CQV) Engineer to join our team in North Carolina. This role involves leading CQV activities for pharmaceutical project sites, ensuring that all processes and systems adhere to regulatory requirements and industry standards. The ideal candidate will have a strong background in CQV within the pharmaceutical sector and a proven ability to manage complex projects from design through to completion.
Key Responsibilities
- Lead and manage CQV activities for pharmaceutical project sites.
- Oversee CQV processes from design through turnover, ensuring compliance with
industry standards and regulatory requirements. - Develop and maintain comprehensive CQV documentation, including C&Q Strategy Plans, Installation Verification (IV), Operational Verification (OV), Installation Qualification (IQ), Operational Qualification (OQ), User Requirements Specifications (URS), System Level Impact Assessments (SLIA), System Risk Assessments (SRA), Component Level Impact Assessments (CLIA), Requirement Documents (RD), Design Qualification Specifications (DQS), Validation Qualification Specifications (VQS)
- Serve as the lead for C&Q utilities, ensuring the integrity and reliability of critical
systems. - Collaborate with cross-functional teams to ensure alignment and successful
execution of projects. - Analyze and interpret data to inform decision-making and strategic planning.
- Provide leadership and guidance to junior engineers and project teams.
- Communicate effectively with stakeholders, presenting technical information clearly
and concisely.
Required Qualifications and Skills
- Bachelor’s degree in Engineering or related field; advanced degree preferred.
- Minimum of 8 years of experience in CQV within the pharmaceutical industry.
- Demonstrated experience as a CVQ Engineer and C&Q utilities lead.
- Proven track record of working on projects from design through turnover.
- Strong expertise in developing and managing CQV documentation.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team in a fast-paced environment.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E