Analytical Scientist – Cleaning Validation Support
VTI Life Sciences
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 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 an experienced Analytical Scientist to support a short-term project focused on cleaning validation for small-molecule biopharmaceutical manufacturing. The assignment requires expertise in analytical method understanding such as LC-MS, HPLC, and TOC and cleaning verification studies using industry-standard techniques.
Contract Position: Analytical Scientist – Cleaning Validation Support
Duration: 2–3 months
Location: Primarily remote, with at least 1 month on-site in South Korea to oversee execution cleaning swab recovery protocols.
o All expenses paid
o Strong writing and communication skills
o No VISA required for 30-day stay (1 month) for USA citizens and green card holders
Key Responsibilities
+ Design and execute cleaning swab recovery studies for small-molecule products using representative surrogate
+ Understanding of analytical test methods such as LC-MS, HPLC, and TOC for swab and rinse samples.
+ Select and qualify representative surrogate compounds for cleaning validation programs based on high potency compound.
+ Generate and review protocols, reports, and supporting documentation using client template protocols and report format that are in alignment with FDA, EMA, and PIC/S expectations.
+ Collaborate with site teams in South Korea to conduct on-site laboratory and validation activities.
+ Provide remote technical support before and after the on-site engagement.
Qualifications
+ Advanced degree (B.Sc. M.S. or Ph.D.) in Analytical Chemistry, Pharmaceutical Sciences, or related field preferred.
+ 5+ years of experience in analytical method validation and cleaning verification.
+ Proven hands-on experience with LC-MS, HPLC, and TOC testing.
+ Direct experience with swab recovery studies for cleaning validation.
+ Familiarity with global regulatory guidelines (FDA, EMA, ICH, PIC/S).
+ Strong technical writing and documentation skills.
+ Availability to travel and work on-site in South Korea for at least one month during the assignment.
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, 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
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