supporting equipment qualification (IQ/OQ/PQ). Experience with aseptic processing is a plus. Experience with CDMOs and external...
, test, and reliability teams. Own the System Product Qualification (PQ) Plan, execution tracking, and readiness reporting...
(IQ/OQ/PQ), and process validation runs. Team Development: Recruit, mentor, and lead a high-performing manufacturing team...
documentation (IQ/OQ/PQ). Execute both off-line and on-line coding and peer reviews to maintain system integrity and compliance...
(IQ, OQ, and PQ). Utilize analytical tools including Minitab and Power BI for statistical analysis and data-driven... Agreement Analysis, and TMV;V&V protocols and IQ/OQ/PQ;Minitab and Power BI;Product lifecycle mgmt., including quality...
, Operational Qualification, Performance Qualification. (IQ/OQ/PQ). Lead the design and development of precision components... Monte Carlo simulation;SAP S/4HANA, SAP ECC and HP ALM;IQ, OQ and PQ;Design for Injection Molding, extrusion, CNC...
on commissioning and qualification methodologies, including IQ/OQ/PQ, FAT/SAT, and risk-based approaches. Ensure that all project... in reviewing, interpreting, and validating complex engineering documentation including IQ/OQ/PQ protocols, FAT/SAT reports...
technical specifications Lead and contribute to validation planning, including IQ/OQ/PQ approaches, CSV frameworks, and risk... requirements: IQ/OQ/PQ, CSV, 21 CFR Part 11 Experience working with or within quality, regulatory, manufacturing, or medical...
in a cGMP environment (IQ, OQ, PQ) including process validation Experience in Project Management and Project Management...
and qualification (IQ/OQ/PQ) in a GMP environment. Familiarity with common biopharma automation platforms (e.g., DeltaV) sufficient...