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Engineer Senior

Calsoft Labs

New Albany, OH

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JOB DETAILS
SKILLS
Analysis Skills, Assembly Equipment, Assembly Line, Change Control, Commissioning, Communication Skills, Continuous Improvement, Cross-Functional, Document Management, Drug Products, GMP (Good Manufacturing Practices), Identify Issues, Leadership, Manufacturing/Industrial Processes, On Site Support, Process Development, Process Engineering, Process Improvement, Process Manufacturing, Product Packaging, Product Support, Project/Program Management, Sales Qualification, Secondary School, Software Engineering, Team Player, Technical Delivery, Technical Leadership, Technical Support, Technical Writing, Validation Plan, Vendor/Supplier Management, Willing to Travel, Writing Skills
LOCATION
New Albany, OH
POSTED
30+ days ago
Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift / Weekend

10% travel required - Must be able to travel internationally for work (Europe/Canada)
18 month contract to start

Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience,
technical writing & Document management system experience - KNEAT or Veeva highly preferred

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 and both on-site work and ~10% travel

Key Functions & Outputs

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.

Technical Leadership:
- Act as site expert in automated/semi-automated device assembly.
- Lead commissioning, qualification, and validation (CQV) of GMP equipment.
- Own and maintain the site master validation plan.

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

Qualifications
- Basic (Education & Experience)
- Doctorate (no experience required)
- OR Master's + 2 years GMP experience
- OR Bachelor's + 4 years GMP experience
- OR Associate's + 8 years GMP experience
- OR High School/GED + 10 years GMP experience

Preferred
Combination product assembly equipment expertise
Cross-functional project leadership experience
Strong teamwork and communication skills
Direct experience in devices, combination products, and packaging operations
Supplier management experience (FDP equipment vendors)
Adaptability in regulated, fast-paced environments
Operational excellence / continuous improvement mindset

About the Company

C

Calsoft Labs

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