CQV Engineer

2 weeks ago

Raleigh, United States Experis Full time

Pay Rate $32-$40/hr
6-12 Month contract with right to hire
1 opening

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The Commissioning, Qualification, and Validation Engineer, Engineer II and 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.

Expectations:
­
The CQV Engineer and Engineer 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 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).

Responsibilities/Assignments:

CQV Engineer

  • 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 and 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 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


Skills Required:

CQV Engineer
  • 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.  

    Or

    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.  

 

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you

 

About ManpowerGroup, Parent Company of:  Manpower, Experis, Talent Solutions, and Jefferson Wells

ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands – Manpower, Experis, Talent Solutions, and Jefferson Wells – creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

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