Engineer Senior

Engineer Senior

Top 3 Must Have Skill Sets:

Expertise in Combination Product Assembly & Packaging Equipment

Strong knowledge of automated and semi-automated device assembly, validation, and troubleshooting Experience in GMP-Regulated Environments

Hands-on experience with technical transfer, regulatory compliance, and supporting commercial manufacturing operations Cross-Functional Project Leadership & Communication Skills

Proven ability to lead technical projects, work across teams, and effectively communicate in a regulated, fast-moving industry

Strong technical writing skills. Red Flags:

Onsite Requirement: This is an on-site role in New Albany, Ohio.

Flexibility with Hours: While not explicitly stated as variable shifts, candidates should expect flexibility given the nature of GMP manufacturing, equipment commissioning, and troubleshooting demands.

Travel Requirement: Must be able to travel 20% required for this role

Candidate must be able to have great communication skills, project management, technical writing and be able adapt based on site priorities.

Too much experience - 8+ years and a B.S.

Summary:

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 ~20% travel

Responsibilities:

Serve as the technical lead for FDP assembly and packaging equipment (new and existing).

Manage commissioning, qualification, and validation activities for GMP equipment, including ownership of the site s master validation plan.

Support technical transfer of new products into the site and ongoing optimization of packaging line performance.

Provide manufacturing troubleshooting and equipment/process improvements.

Build and leverage networks of technical experts across our global sites.

Support operational excellence initiatives to increase throughput, productivity, and efficiency

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

Basic Qualifications:

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

Pay range is $39 - $44 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

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