| Validation Engineer at Remote, Remote, USA |
| Email: [email protected] |
| From: Akash Sharma, Tekinspirations [email protected] Reply to: [email protected] Position: Validation Engineer Location: Swift water, PA (Hybrid) Duration: 6+ Months MOI: Video LOOKING FOR STRONG CLEANING VALIDATION CANDIDATE WHO HAS EXPERIENCE WITH PHARMA MANUFACTURING PRODUCTION EXPERIENCE. I am STILL Seeking a strong CLEANING VALIDATION specialist with PRODUCTION MANUFACTURING experience for my Pharm client in Swiftwater, PA. Highly motivated hiring manager who is interviewing quickly. This manager gives a VERY IN DEPTH AND TECHNICAL INTERVIEW, and he quickly can discern if a candidate does not have the experience listed on their resume. Candidates will be prescreened by savvy contractor at Lenox who has done this role. Imposters will not be successful trying to interview for this role. MUST HAVE: Experience in cleaning validation in the biologics or vaccine industry to include the following: o Experience in authoring, reviewing, executing and approving validation documents. o Interface with Quality organization and the ability to defend rationale in validation documents. o Ability to develop cleaning cycle and lead the investigation or trouble shooting. o Ability to review and analyze data. Cleaning Validation experience o Acceptance criteria determination o Sampling plans and sample size determination o Rinse and Swab sampling experience o Bracketing and worse case rating o QC testing requirements o Dirty hold times and clean hold times EXCELLENT communication skills Ability to manage, execute and troubleshoot on their own Strong Microsoft Suite skills (Word, Excel, Project, Outlook) REQUIREMENTS: BS/MS degree 2+ total years of experience working in a biologic, vaccine or pharma industry Experience writing and revising documents (e.g. testing methods, protocols, reports) Experience performing testing in a GMP setting Proficiency in utilizing documentation system to author protocols and reports Experience participating in teams and collaborative work environments. Team environment a must E Doc/GEODE+ experience with a working knowledge of templates, workflows and approval process Strong root cause analysis with cGMP experience. Keywords: access management microsoft Pennsylvania Validation Engineer [email protected] |
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| Fri May 17 06:35:00 UTC 2024 |