- Sumitomo Pharma (Trenton, NJ)
- … of the following activities - equipment and utilities qualification/ validation , process development, process validation , continued process ... 8 - 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry Validation experience with multiple therapeutic modalities (eg API,… more
- Merck (Rahway, NJ)
- …NJ. The group sits within the Manufacturing Division and is responsible for pharmaceutical process development and supply for small molecule solid dosage drug ... as products enter Phase IIb through regulatory filings and process validation and supports supply for several...all employees. Key Responsibilities: + Plan, conduct, and interpret pharmaceutical process development studies with manager and… more
- Integra LifeSciences (Plainsboro, NJ)
- …criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of ... change and the documentation path of a compliant process . The candidate must possess technical writing experience in protocol generation and procedure generation.… more
- Cognizant (Trenton, NJ)
- …in cross-functional program leadership meetings, ensuring alignment between automation, process engineering, digital/MES, and quality teams + Serve as the ... software testing strategies + Identification of any remediation effort required on process control software + Identify and analyze risks of technical nature… more
- Insight Global (Hopewell Township, NJ)
- …Description Our top Pharmaceutical client is seeking a Documentation and Validation specialist to join their External Call Center team within their Patient ... resource will have experience with Salesforce Service Cloud, Visio, PPT, and other process documentation tools to document workflows and validation . We are a… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Perform independent review and approval of initial Commissioning, Qualification, and Validation (CQV) lifecycle documents and subsequent changes. + Review and ... -Experience as a CQV, QA, and/or QC representative within Pharmaceutical /Drug Substance Manufacturing (API, Sterile, Non-Sterile or Biological products) or… more
- Bristol Myers Squibb (Summit, NJ)
- …qualification and support requests. + Provides technical support and guidance on Validation , Quality Process , and equipment qualification issues. Interfaces with ... documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry. + Strong working knowledge of ISPE guidance, 21 CFR… more
- BeOne Medicines (Pennington, NJ)
- …Biochemistry laboratory routine operations, including but not limited to validation , SOP revisions, specification updates, testing records, personnel training and, ... Health and Safety (EHS) standards. + Ensure timely completion of testing (eg, in- process , DS release, DP release, and stability testing) to ensure timely generation… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and plans, executes and functionally directs Process /Cleaning Validation /Study assignments and projects, which require sound pharmaceutical /engineering ... the organization. Managing the post approval projects. Essential Functions: + Prepare validation protocols & reports for manufacturing process and cleaning … more
- Merck (Rahway, NJ)
- …center, for sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group ... products, including critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the… more
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