, Chronometer. Understanding of GxP, GMP process. Good exposure and understanding of IT infra like Anti-Virus, AD, Asset...
Job Title: Engineer, GMP Drug Delivery Medical Device (JP13653C) Location: Cambridge, MA 02138 OR Thousand Oaks, Ca... and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development...
Job Description: The GMP Operational Quality Specialist works with a high degree of independence to provide QA... Analytical support for release of commercial products. The GMP Operational Quality Specialist executes routine tasks...
. Experience within the biotech or pharmaceutical industry and working knowledge of Good Manufacturing processes (GMP) and Computer... Systems Validation (CSV). Working Conditions: Hybrid in-office required – 3 days in office. On-call availability...
Job Title: Engineer, GMP Drug Delivery Medical Device (JP13357C) Location: Cambridge, MA 02138 OR Thousand Oaks, Ca... and lifecycle management of Physical GMP Test Methods, lifecycle management of integrated testing machines, development...
Validation Engineer II Location: Initial training Boston, MA and then relocation to Braintree, MA Work Schedule... maintenance and optimization of state-of-the-art GMP facilities and equipment. The ideal candidate will be responsible...
Payrate: $60.00 to $61.00/hr Summary: The Validation Engineer is responsible for Qualifying state-of-the-art GMP..., Reviewing, and Executing all Validation Documentation associated with Integra’s Validation Programs Collaborate with cross...
, as necessary. Validation Documentation: Draft, review, and revise validation protocols, test plans, and reports, ensuring... alignment with regulatory standards. Maintain meticulous records of validation activities for audits and inspections. CQV...
stakeholders by working with project teams and stakeholders to mitigate them during clinical development, validation, submission... governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for GMP/GDP...
and resolve issues in a GMP-compliant manner. Interpret multidimensional data sets and make recommendations on process... based on complex data sets. Experience in computer systems validation and commissioning for the pharmaceutical industry...
and Validation) department, as well as revising and writing procedures, and acting as document coordinator . Primary... process. Initiate Change Controls as required for Engineering/Facilities operations. Manage Facilities Engineering GMP...
for updating, authoring, and reviewing FEV (Facilities, Engineering, and Validation) standard operating procedures... and other controlled documents. Other duties include collaborating with stakeholders from multiple departments, managing GMP documents...
, and validation of analytical methods: Primary Responsibilities: Optimize, technical transfer, qualification, and validation... of complex GMP release and stability assays including cell-based functional assays, flow cytometry methods, ddPCR, ELISA, and NGS...
analysis, and laboratory operations within a GMP environment: Primary Responsibilities: Work with client team on routine... testing and if needed for method transfer or qualification Make and Review entries in DELTAV, CMMS, validation software, LIMS...
Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids, etc.) needed for internal... qualification, and validation documentation for adequacy and compliance. Review batch record documentation, ensure compliance...
a pivotal role in managing activities within a GMP-regulated environment, ensuring adherence to cGMPs and regulatory standards... field. Experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy manufacturing. Knowledge of current GMP...
in collaboration with process development colleagues and GMP team. Key Responsibilities: Autonomously design, execute, and analyze..., proactively collaborate transversally with all DS teams, Analytical R&D, GMP teams, etc, in an agile and open way ensuring good...
development, qualification, and validation as well as GMP activities (release and stability) are executed. The role of Scientist...
Responsibilities: Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids..., equipment qualification, and validation documentation for adequacy and compliance. Review batch record documentation, ensure...
their growth and development. Oversee the development and validation of core analytical methods, with a focus on chromatographic... techniques. Collaborate with project teams to design, oversee and review relevant analytical methods, validation protocols...