About this opportunity
Crystal Equation Corporation lists this Senior Process Development Engineer opportunity in new albany, Ohio. Review the employer’s description below for duties, qualifications and application requirements.
Job description
The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio.
This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands
Responsibilities
Technical Leadership:
Act as site expert in automated/semi-automated packaging equipment and device assembly.
Lead equipment characterization to optimize operating conditions and to establish appropriate process parameters, operating ranges, and controls.
Lead commissioning, qualification, and validation (CQV) of GMP equipment.
Own protocols, reports, risk assessments and other technical documentation
Project Management:
Support technical transfer of product portfolio into the Ohio site.
Drive continuous improvement in device assembly and packaging line capacity/performance.
Communicate across the network to deliver technical milestones.
Operational Excellence:
Analyze, design, and implement manufacturing/business process improvements.
Drive productivity, throughput, and efficiency gains.
Quality and Document Management Systems:
Able to author and manage various documents/protocols/reports
Deviation/CAPA/EV Owner
Change Control Owner
Relationships:
Build networks with commercial and clinical operations.
Provide support for equipment standardization, troubleshooting, and performance trending
Required Skills
Strong combination of hands‑on automated packaging equipment experience, GMP, equipment verification, technical writing/execution, and KNEAT or Veeva experience, who are also fully comfortable with the required shift flexibility.
Hands‑on GMP Packaging Equipment Experience
Minimum 4+ years GMP experience with a B.S., including direct hands‑on experience with automated/semi-automated packaging or device assembly equipment, troubleshooting, characterization, and establishing process parameters/ranges.
CQV & Technical Documentation Experience
Demonstrated ability to lead/support commissioning, qualification, and validation (CQV) and independently author protocols, reports, risk assessments, deviations/CAPAs, and change controls. Experience with KNEAT, Veeva, or similar GMP document systems strongly preferred.
Schedule & Travel Flexibility
-Must be able to provide on-site support across day, swing/night, and weekend shifts based on manufacturing needs
Preferred Skills
Combination product assembly equipment expertise
End to end integrated packaging equipment
Hands of experience with euipment to establish parameters
Cross-functional project leadership experience
Strong teamwork and communication skills
Direct experience in devices, combination products, and packaging operations
Adaptability in regulated, fast-paced environments
Operational excellence / continuous improvement mindset
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Worksite address
new albany, OH, 43054, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.