Cleaning Validation Engineers

Inc. (Vti); Raleigh (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

VTI Life Sciences is looking for ambitious Cleaning Validation Engineers to join their team at a pharmaceutical manufacturing facility in Raleigh, NC. You will engage in critical tasks such as developing cleaning validation plans, collaborating with various departments, and ensuring compliance with regulations. This role offers opportunities for professional development in a supportive and innovative environment while contributing to important projects within the life sciences sector.

Benefits

Competitive compensation

Excellent benefits

Matching 401K

Professional development and training

Qualifications

• 4+ years for Cleaning Validation Engineer and 8+ years for Senior Cleaning Validation Engineer.
• Experience in a CDMO or drug product facility is required.
• Strong knowledge of Kneat and current industry knowledge of Cleaning Validation.

Responsibilities

• Document strategies for executing Cleaning Validation at the site.
• Write and review cleaning and sanitization procedures.
• Ensure plans comply with regulations and support successful qualification.

Skills

Cleaning Validation

Regulatory Compliance

Kneat

Communication Strategy

Liaising with Teams

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; 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; Experience - 8+ years; Location - North Carolina, USA (On-Site); Duration - Through the end of the year (Initial Contract)

Job Description

• Seeking 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, involving operations, QA, QC, process support, supply chain, etc., and gain necessary alignments.
• Liaise with operational readiness teams 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; maintain the Cleaning Validation Master Plan.
• Coordinate with the CV team at their sister site in Europe 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 with the CV lead and launch with the head of CQV.
• Work with project managers to develop tracking tools for CV activities.
• Ensure plans comply with regulations and support successful qualification and inspections.
• Serve as SME for cleaning validation presentations to Regulatory (FDA), auditors, and internal teams.
• Identify SOPs and timelines; collaborate to ensure delivery.
• Partner with QC 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 on-site CV execution.
• Collaborate with CQV leads, CV lead, REs, and QA on implementation.
• Develop documentation plans and work with Kneat leads on templates.
• Localize documents and SOPs to 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 collaborative work environment. We are committed to providing exciting career opportunities in a trusting, respectful, open, and innovative environment.

As a leading global validation services organization, VTI is always seeking talented validation professionals for our multinational offices. We offer some of the best salary and benefit packages in the industry for full-time employees. www.validation.org