- Sun Pharmaceutical Industries, Inc. (Hopewell, NJ)
- …batch release, equipment/ instrument preventive maintenance/ calibration/ qualification/ validation as per good manufacturing practices/ good documentation ... conclusions, Corrective and Preventive actions are adequate. Reviews Cleaning Validation related documents (plans, protocols, reports, projects). Supports Quality… more
- Sun Pharmaceutical Industries, Inc. (Lawrenceville, NJ)
- …specs review, SAP authoring, DB lock support topline results validation /interpretation, CSR co-authoring and eventual regulatory strategy development and submission. ... clinical development experience Demonstrated understanding of the drug development process Demonstrated expertise with clinical trial design, study implementation,… more
- Sun Pharmaceutical Industries, Inc. (Lexington, MA)
- Job Summary Performs QA review of testing records of raw materials, in- process and finished products, stability samples, and non-routine sample analyses per ... inspections or internal/external audits Perform review of release, stability, validation , analytical quality control tests on raw materials, in-processing and… more
- Amgen (New Albany, OH)
- …+ 6 + years biotech or pharmaceutical industry experience + Significant Validation experience on Pharmaceutical /Medical Device Process and Equipment ... activities for the site. You will lead and coordinate the site validation process for equipment and combination products, and establish procedures for equipment… more
- Eurofins (Columbia, MO)
- …areas of bio/ pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. Eurofins BPT-Columbia is ... computer systems used in the manufacture and testing of pharmaceutical products. + Maintain validation documentation to...and testing of pharmaceutical products. + Maintain validation documentation to ensure timely retrieval in support of… more
- Kelly Services (Anasco, PR)
- …the medical device and/or pharmaceutical manufacturing environment in manufacturing process , quality or validation engineering position and preferably with ... Specialist** to work with one of out top pharmaceutical /biotechnology industry clients at **Anasco, PR.** With us, it's...EU MDR or MDD remediation projects, compliance projects and process validation required. + Experience with managing… more
- Eurofins (Lancaster, PA)
- …areas of bio/ pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. Job Summary: Eurofins ... Eurofins is the world leader in the bio/ pharmaceutical testing market. With over €5.3 billion in...to join our Cell & Molecular Method Development and Validation team in Lancaster, PA. The Department Manager is… more
- Eurofins (Lancaster, PA)
- …areas of bio/ pharmaceutical manufacturing, including method development, microbiology, process validation and quality control. Job Summary: Are you ... Eurofins is the world leader in the bio/ pharmaceutical testing market. With over €5.3 billion in...develop your career? Eurofins Small Molecule Method Development and Validation team is seeking an entry level scientist to… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …Liquids & Semi solid manufacturing, and Packaging + Thorough knowledge of cGMPs, pharmaceutical processing, process and equipment validation , cleaning ... Princeton, NJ on a hybrid work schedule. **Roles & Responsibilities** + Oversee process validation activities (PPQ) and provide life cycle management support for… more
- Danaher Corporation (Hauppauge, NY)
- …talent to develop the next generation of life-changing therapeutics. The Manager, Validation and Laboratory Operations for Cytiva is responsible for leading paid ... or Lead Technical consultation with customers (internal and external), involving validation testing plans and data review, test recommendations based on regulatory… more
- PCI Pharma Services (Bedford, NH)
- …Combination of equipment qualification, process validation , or cleaning validation is acceptable; QA pharmaceutical experience also preferred. * ... of PCI. **JOB SUMMARY** Reporting to the Senior Manager process Validation , the Process ...industry standards and regulatory trends as they pertain to Validation of pharmaceutical or biopharmaceutical processes. **PROFESSIONAL… more
- Catalent Pharma Solutions (Bloomington, IN)
- …standards and requirements of company policies and FDA regulations. **The Process Validation Manager's responsibilities include managing multiple projects to ... managing protocol and report development, execution and approval associated with process validation , reviewing and approving documentation, evaluate and… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …QA Oversight department at Regeneron is adding to their team! The **Manager, Process Validation Oversight** leads a department responsible for the qualification ... of the equipment, systems, and processes validation for our CMO and partner groups in accordance...if you: . Have previous quality experience in the pharmaceutical industry. . You continuously seek to improve processes… more
- Astellas Pharma (Westborough, MA)
- … Validation work may also include the following areas based on experience: + Process Validation /PPQ + Aseptic Process Simulation Validation + ... **Senior Validation Specialist, Quality Assurance** Do you want to...you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries… more
- United Therapeutics (Silver Spring, MD)
- …level: Bachelor's Degree in a scientific field and 5+ years of relevant validation experience in a pharmaceutical /cGMP environment + For the **_Senior ... issues including, but not limited to: equipment, computer, or process -related, where precedent may not exist, referring only the...in an _engineering_ field and 5+ years of relevant validation experience in a pharmaceutical /cGMP environment +… more
- Catalent Pharma Solutions (Chelsea, MA)
- …industry practices. Validation activities include equipment, instrument, cleaning, computer and process validation . This is a full time, salaried role, The ... projects related to reviewing, authoring, and executing specifications and validation documentation for process equipment/systems, laboratory automated… more
- Contract Pharmacal Corp (Hauppauge, NY)
- …The Junior Validation Engineer (Technical Services) is responsible for performing process validation , cleaning validation and equipment validation ... to operations and quality teams during the execution of process and cleaning validation activities. + Develop...industry in lieu of Master's degree. + Experience with pharmaceutical manufacturing and packaging equipment / process .… more
- ThermoFisher Scientific (Allentown, PA)
- …Qualification (PPQ) documentation, including Control Strategy, Product Knowledge assessment, Process Failure Modes and Effects Analysis, Validation Strategy, ... equivalent validation experience including five years of food or pharmaceutical packaging or cGMP experience + Knowledge of Controlled Temperature Unit Operation… more
- Curia (Albuquerque, NM)
- …with minimal disruption to production and facility shutdown schedules + Direct validation process improvements and goals for Curia using current regulations ... Responsibilities include the following. + Develop and continuously improve site validation program including equipment, process , cleaning, sterilization and CSV… more
- Kelly Services (Pennington, NJ)
- …+ Analyzing validation data and prepare detailed reports documenting the validation process , findings, and recommendations. + Identifying opportunities for ... process improvements, efficiency gains, and cost reductions in validation activities. + Ensuring compliance with cGMP, FDA, EMA, and other relevant regulatory… more
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