manufacturing engineer Indiana, PA
Job description
SUMMARY:• Support execution of the Commissioning & Qualification activities for new Vial Filling Equipment e.g. filler, isolator/VHP, glove testers, particle monitoring systems including FAT, SAT, IQ and OQ.
•Responsible for delivering cycle development for the process including VHP cycles for Isolator & transport systems and preparation of required GMP documentation for filling process and recipes.
•Coordinate technical deliverables within Filling to support successful process and product launches.
•Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimization using tools such as DMAIC and FMEA.
•Manage change in the Vial & Syringe Filling area as per site change control procedures.
•Support establishment of electronic batch record system for the Filling process
•Lead/participate in Standard Work, 5S, TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings.
•Participate in regulatory inspections e.g. FDA, DEA inspections
•Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processes Required Skills.
•Exposure or Front-line support to aseptic filling lines.
•Demonstrated ability to solve technical problems and implement projects.
•Strong interpersonal and communication skills.
•Ability to work effectively with outside suppliers.
•Knowledge of C4I and LEAN methodologies.
•Excellent verbal and written communications skills.
•Strong problem-solving skills.
•Strong Mechanical Aptitude. Education And Experience:
•Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
•Minimum 3-5 years working in a cGMP environment.
•The preferred candidate will have extensive aseptic filling experience.
•Ability to manage teams to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
•Ability to adapt to changing priorities as project demands change.
•CQV experience and experience with facility start up advantageous.
•Ability to explain complex technical issues to external customers / agencies.
•Demonstrated excellence in planning and organizational skills.
Job Type: Full-time
Pay: $25.29 - $49.90 per hour
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
- In-person
Work Location: In person
