Cleaning Validation Engineer

VTI Life Sciences•Bethesda Area, MD

7d•Onsite

About The Position

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers who are looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help 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 seeking a Cleaning Validation Engineer to work on-site at our client's biotech facility in the Bethesda, MD area. Job Description 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 delive Work with the CQV leads, CV lead, REs, and QA on the implementation of the CV strategy in their respective areas 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. VTI offers professional development, training, competitive compensation, excellent benefits, a matching 401K, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in a work environment that values trust, respect, openness, teamwork, creative talent, enthusiasm and diligence. As one of the leading global Commissioning, Qualification and Validation Services organizations, VTI is always looking for innovative, talented and experienced validation professionals for our multinational and global offices. We offer some of the best salary and benefit packages in the industry for our full-time/permanent employees. www.validation.org

Requirements

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

Responsibilities

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 delive
Work with the CQV leads, CV lead, REs, and QA on the implementation of the CV strategy in their respective areas