Location: Northeast/ Pennsylvania
Immediate and exceptional opportunity to join a dynamic team of validation experts within their field. Validation Technologies, Inc. is immediately seeking a Senior-Level Validation Engineer/Cleaning Validation Guru to complete our biotech validation “dream team,” the Northeast/Pennsylvania region.
This is a highly visible role within our global organization. One in which a great deal of success will be determined by the Sr. Cleaning Validation Engineer’s ability to lead and execute our high-profile validation projects for one of the most prestigious Biopharmaceutical companies in the world!
Validation Technologies offers competitive compensation, excellent benefits, 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.
Validation Technologies, Inc. (VTI) strives to maintain and inspire professional excellence by providing Commissioning and Qualification Services to the Pharmaceutical, Biotech /Biologics and Medical Devices Industries.
In This Position, You Will:
- Be in a highly influential role and have a once-in-lifetime opportunity to make an immediate impact within one of the top global biopharmaceutical companies in the world!
- Have a proven track-record of successful cleaning validation project execution
- Join dynamic cleaning validation team responsible for the installation qualification (IQ) and operational qualification (OQ) related to IOQ equipment and support cleaning validation/ cleaning verification activities related to the purification process (i.e. Chromatography Skids; UF/DF Skids; Buffer; Tanks, etc.)
- Perform regular clean in place/clean out of place and steam in place/steam out of place (CIP/SIP).
- Summarize and evaluate cleaning validation findings in a clear, orderly and succinct manner
- Perform cleaning validation sampling using standard operating procedures (SOP)s to evaluate cleaning procedures
- Research and author Risk Assessments related to Cleaning & Filtration
- Write cleaning validation/verification protocols, technical documents, IOQ protocols and final reports
- Over 5+ years of Validation and Qualification experience in Biotech/Pharma industries
- Bachelor’s degree or higher in Engineering, Life Sciences or related discipline (Engineering, ChemEng, Chemistry, Biology, etc.)
- Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities (i.e. UF/DF skids, tanks, buffers, lyophilizer equipment, etc.)
- Experience with production scale lyophilization validation and lyophilizer equipment; Big Plus
- Thorough knowledge of cGMP/FDA regulations and clean room environment
- Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, IOQ protocols and final reports
- Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
- Must have strong ability to organize and manage multiple tasks in a fast-paced environment
Validation Technologies Offers:
As one of the leading global 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 as well as competitive hourly pay for our contractors. www.validation.org
Validation Technologies, Inc - 18 months ago