Job Title: Senior Process Development Engineer
Location: New Albany, Ohio (On-Site)
Job Summary: We are seeking a skilled engineering professional to support commercial GMP final drug product operations through hands-on technical leadership in automated packaging and device assembly equipment. Our team is looking for someone who can drive equipment characterization, qualification, technical documentation, and process improvement while supporting on-site manufacturing needs across a flexible schedule.
Responsibilities:
- Lead technical support for automated and semi-automated packaging equipment and device assembly, including troubleshooting, characterization, and process parameter development.
- Support commissioning, qualification, and validation activities by authoring and executing protocols, reports, risk assessments, and related technical documentation.
- Partner with Manufacturing, Quality, Engineering, Validation, Automation, Packaging Engineering, and external suppliers to support technical transfer, equipment modifications, FAT/SAT activities, and operational readiness.
- Drive continuous improvement by analyzing downtime, recurring failures, throughput constraints, and process trends to improve reliability, capacity, and efficiency.
Required:
- Bachelor’s degree with 4 years of experience, or a higher/lower degree combination that meets the stated minimum qualifications.
- At least 4 years of GMP experience, with hands-on experience supporting automated or semi-automated packaging equipment or device assembly equipment.
- Experience with equipment troubleshooting, characterization, and establishing operating conditions, process parameters, ranges, and controls.
- Experience supporting commissioning, qualification, and validation activities, along with technical writing and execution of protocols, reports, risk assessments, deviations, CAPAs, and change controls.
- Experience with KNEAT, Veeva, or a similar GMP document management system is strongly preferred.
- Must be able to work on-site and provide flexible coverage across day, swing, night, and weekend shifts based on manufacturing needs.
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