Quality Engineer, Life Sciences (130390964)
Entegris is seeking a hands-on, innovative Quality Engineer to provide quality support for products and site practices for the emerging Life Sciences business. The Quality Engineer must be self-directed with the ability to work collaboratively to complete projects and assignments, which will include providing technical expertise and support for the Entegris Aramus™ product lines. This role is based in our Billerica, Ma high purity packaging manufacturing facility and reports to the Life Sciences Quality Director.
- Reviews productions records, releases product and generates Certificated of Analysis
- Leads product, process and customer issue resolution during all phases of the product life cycle using tools such as 8D, Six Sigma DMAIC and Statistical Process Control to ensure effective corrective and preventive action and closure within timing goals.
- Supports and maintains failure analysis process. Ensures feedback, corrective action communication, and implementation are consistent with customer expectations.
- Requests and preps samples for Bioburden, Endotoxin and Dose Audit monitoring performed by outside labs. Review, tracks and trend test data.
- Review Cleanroom environmental monitoring data, may be required to perform testing as a back-up. Perform investigation of Out of specification results and impact on product.
- Generates, analyzes, and reports on the levels of product quality within the assigned manufacturing areas, including Pareto, Statistical Process Control, and Process Capability Studies.
- Participates in material disposition decisions to support ongoing production for areas of responsibility.
- Participates in continuous improvement (Lean and Six Sigma projects) within assigned manufacturing areas and quality processes.
- Authors and/or reviews Standard Operating Processes, work instructions, test specifications, Equipment/Cleanroom IQ/OQ/PQ documents and other documents for accuracy.
- Supports ISO certification, customer and supplier audits as a subject matter expert, as needed.
- Ability to travel, both domestically and internationally to support product and customer needs.
- Bachelor of Science degree or equivalent in technical or life sciences discipline (engineering, materials, microbiology, ) with a minimum 5 years of experience as a quality engineer in a manufacturing environment; preferably pharmaceutical or biopharmaceutical environment
- Experience with microbiological testing and aseptic technique preferred
- Experience with applicable validations such as gamma sterilization, biocompatibility and stability
- Experience with applicable quality tools such as FMEA, SPC, DOE and analysis tools such as: histograms, pareto, process mapping, cause and effect diagrams, 8D problem solving & Six Sigma methodology;
- Knowledge of ISO 13485 requirements and GMP regulations preferred
- Knowledge of ISO 9001 quality management systems