VTI Life Sciences · 1 day ago
Cleaning Validation Engineer
Bethesda, MD
Full-time
Onsite
Senior Level
5+ years expVTI Life Sciences is seeking a Cleaning Validation Engineer to support their teams in the pharmaceutical, biotechnology, and medical device industries. The role involves writing and reviewing cleaning procedures, ensuring compliance with regulations, and collaborating with various teams to implement cleaning validation strategies.
Biotechnology
Responsibilities
The candidate needs to have current industry Cleaning Validation knowledge, including autoclaves, for drug products
The candidate needs to be able to work across functions and departments
Write and review cleaning and sanitization procedures and maintain the Cleaning Validation Master Plan
Define roles and responsibilities during CV and gain alignment from supporting teams
Together with the CV lead, develop a communication strategy to ensure the site is informed about CV and work with the head of CQV to launch
Work with project managers to develop tracking tools and visibility to CV activities
Ensure our plan aligns with all necessary regulations and will support successful qualification and future site regulatory inspections
Identify all necessary SOPs and need by dates and work with owning functions to ensure delivery
Work with the CQV leads, CV lead, REs, and QA on the implementation of the CV strategy in their respective areas
Qualification
Required
5+ years of Cleaning Validation experience in Biotech/Biologics/Pharma industries
Bachelor's degree or higher in Engineering, Chemistry, Biology, Chemical Engineering, or related discipline
Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities in a solid dose facility
Thorough knowledge of cGMP/FDA regulations and clean room environment
Demonstrated ability in reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
Strong interpersonal skills, attention to detail, excellent review and analytical skills
Must be able to organize and manage multiple tasks in a fast-paced environment
Benefits
Competitive compensation
Excellent benefits
A matching 401K
Professional development
Training
Company
VTI Life Sciences
VTI Life Sciences is an ISO 9001:2000 Certified Company with the experience, expertise, and commitment to provide the superior service required to meet all of your validation and compliance needs.
51-200 employees
H1B Sponsorship
VTI Life Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase