VTI Life Sciences is hiring: Cleaning Validation Engineers - North Carolina in W

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VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer opportunities to support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.

We are looking for 2 Cleaning Validation Engineers to work onsite at our client's pharmaceutical manufacturing facility in the Raleigh, NC area: one (1) Cleaning Validation Engineer and one (1) Senior Cleaning Validation Engineer.

Job Details

• Job Title: Cleaning Validation Engineer
• Industry: Pharmaceutical Manufacturing
• Experience Level: 4+ years
• Location: North Carolina, USA (On-Site)
• Duration: Through the end of the year (Initial Contract)

• Job Title: Senior Cleaning Validation Engineer
• Industry: Pharmaceutical Manufacturing
• Experience Level: 8+ years
• Location: North Carolina, USA (On-Site)
• Duration: Through the end of the year (Initial Contract)

Job Description

• Looking for a Cleaning Validation Engineer, specifically for drug product parts washers.
• Previous work in a CDMO or drug product facility is required.
• Strong working knowledge of Kneat.
• Current industry knowledge of Cleaning Validation, including autoclaves, for drug products.
• The ability to work across functions and departments.
• Participate in CV conversations for CQV involving operations, QA, QC, process support, supply chain, etc., and gain alignment.
• Liaise with the operational readiness team and third-party contractors to build connections and define interactions related to cycle development and hold times.
• Document a strategy for executing CV at the site.
• Write and review cleaning and sanitization procedures and maintain the Cleaning Validation Master Plan.
• Collaborate with the CV team at the European site to clone SOPs, methods, etc., and develop localization plans for North Carolina.
• Define roles and responsibilities during CV and gain support from teams.
• Develop a communication strategy for CV awareness and work with the head of CQV for launch.
• Work with project managers to develop tracking tools for CV activities.
• Ensure plans comply with regulations and support successful qualification and regulatory inspections.
• Serve as SME for cleaning validation presentations to FDA, internal, and external auditors.
• Identify necessary SOPs and work with teams to ensure timely delivery.
• Partner with QC teams to determine CV methods and sampling strategies.
• Coordinate with Supply Chain to develop material resourcing and storage strategies for CV.
• Develop training strategies for personnel prior to CV execution.
• Work with CQV leads, CV lead, REs, and QA on CV implementation.
• Create high-level documentation plans and collaborate with Kneat leads on templates.
• Localize documents and SOPs for the client site.
• Investigate deviations and discrepancies.

VTI Life Sciences provides professional development, training, competitive compensation, excellent benefits, a 401K match, and a collaborative work environment. We are committed to offering exciting career opportunities in a culture that values trust, respect, openness, teamwork, creativity, enthusiasm, and diligence.

As a leading global organization in Commissioning, Qualification, and Validation Services, VTI seeks innovative, talented validation professionals for our international offices. We offer competitive salaries and benefits.