Cleaning Validation Engineers

Inc. (Vti); North Carolina; On-site; USD 70,000 - 90,000; Full time

Job summary

A leading global Validation Services organization is seeking Cleaning Validation Engineers to work on-site in North Carolina. The role involves developing cleaning validation strategies, ensuring compliance, and collaborating across departments in the pharmaceutical manufacturing industry.

Benefits

Competitive Compensation

Excellent Benefits

401K Matching

Professional Development

Qualifications

• 4+ years experience for Cleaning Validation Engineer, 8+ years for Senior Engineer.
• Experience in a CDMO or drug product facility required.

Responsibilities

• Develop and document cleaning validation strategies and procedures.
• Coordinate with teams for compliance and successful qualification.
• Serve as SME for cleaning validation presentations.

Skills

Cleaning Validation

Kneat

Regulatory Compliance

Job description

VTI Life Sciences (VTI)

is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity 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 Titles and Details

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

• Senior Cleaning Validation Engineer
• Industry: Pharmaceutical Manufacturing
• Level of Experience: 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.
• Experience 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.
• Ability to work across functions and departments.
• Participate in CV conversations for CQV, including all necessary functions such as operations, QA, QC, process support, supply chain, etc., and gain alignment as needed.
• Coordinate with the operational readiness team and third-party contractors to 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 CV team at their European site to clone SOPs and develop localization plans for North Carolina.
• Define roles and responsibilities during CV and gain alignment from supporting teams.
• Develop a communication strategy for CV awareness and launch in collaboration with the CV lead and head of CQV.
• Work with project managers to develop tracking tools for CV activities.
• Ensure compliance with regulations to support successful qualification and regulatory inspections.
• Serve as SME for cleaning validation presentations to Regulatory bodies, internal, and external auditors.
• Identify necessary SOPs and work with responsible functions to ensure timely delivery.
• Partner with QC to determine CV methods and sampling strategies.
• Coordinate with Supply Chain to develop material resourcing and storage strategies for CV activities.
• Develop personnel training strategies for CV execution.
• Collaborate with CQV leads, CV lead, REs, and QA on CV implementation.
• Create high-level documentation plans and work with Kneat leads on templates.
• Localize documents and SOPs for the client site.
• Investigate deviations and discrepancies.

VTI Life Sciences strives to maintain and inspire professional excellence by providing Commissioning, Qualification, Quality Engineering, Automation, and Validation Services to the Pharmaceutical, Biotechnology, Biologics, and Medical Device industries. We offer professional development, training, competitive compensation, excellent benefits, a matching 401K, and a stimulating work environment. We are committed to providing exciting career opportunities in a culture that values trust, respect, openness, teamwork, creativity, enthusiasm, and diligence.

As a leading global Validation Services organization, VTI is always seeking innovative, talented validation professionals for our multinational offices. We offer competitive salaries and benefits for our full-time employees. www.validation.org