Process Engineer (Day Shift)
equipment to ensure the fulfillment of all requirements including IQ/OQ/PQ validation and verification activities. Ability...
equipment to ensure the fulfillment of all requirements including IQ/OQ/PQ validation and verification activities. Ability...
Documentation development and execution experience (ex. - FAT, SAT, IQ, OQ, PQ, Risk Assessments, URS) in the Life Science Industry...
efficiency Validation & Analysis Develop and execute validation protocols (IQ/OQ/PQ) and test methods Analyze test data... Experience with validation (IQ/OQ/PQ) and design controls Understanding of statistical analysis and data-driven decision-making...
/PQ/EQV/TMV) for new product introductions and production scale-up. Apply methodologies including Design for Reliability...
activities including IQ/OQ/PQ and MSA/GR&R to sustain validated production processes Coating Production & Supplier Support... execution) Validation methodologies (IQ/OQ/PQ), MSA/Gage R&R Quality & regulatory standards (ISO 13485, FDA, CAPA) Special...
, and manufacturing transitions Partner with Operations, Engineering, and Validation teams on IQ/OQ/PQ and revalidation efforts Monitor...
execution of process validation, equipment qualification (IQ/OQ/PQ), and scale-up activities. Support regulatory submissions...
Must-Have Skills * Process Validation (IQ/OQ/PQ) – Hands-on validation protocol development and execution. Capital Project Management.../OQ/PQ). Manage capital equipment upgrades, replacements, and installation projects. Develop and improve manufacturing...
capital projects preferred. Top 3 Technical Skills Required: Demonstrated experience in validations IQ, OQ, PQ...
production environment along with using troubleshooting techniques to solve PQ related issues. KEY DUTIES/RESPONSIBILITIES...