Senior Process Development Engineer - Packaging Equipment

Crystal Equation Corporation; New Albany (OH); On-site; USD 54,000 - 61,000; Full time

Benefits offered by this job

Full benefits

Paid time off

Medical/dental/vision/life insurance

401K

Parental leave

Job summary

Crystal Equation Corporation in New Albany, OH seeks a Senior Process Development Engineer – Packaging Equipment onsite to lead CQV, process optimization and equipment performance. You will drive line improvements, generate technical documentation, and coordinate cross-functional teams to support FDP operations.

The role requires on-site presence, flexible scheduling, and a strong background in automated packaging equipment and device assembly within regulated environments.

Qualifications

• Preferred combination product assembly equipment expertise.
• End-to-end integrated packaging equipment experience.
• Hands-on experience with equipment parameter establishment.
• Cross-functional project leadership experience.
• Strong teamwork and communication skills.
• Direct experience in devices, combination products, and packaging operations.
• Supplier management experience with FDP equipment vendors.
• Adaptability in regulated, fast-paced environments.
• Operational excellence and continuous improvement mindset.

Responsibilities

• Act as site expert in automated packaging equipment and device assembly.
• Lead equipment characterization to optimize operating conditions and controls.
• Lead CQV activities for GMP equipment commissioning and qualification.
• Own protocols, reports, risk assessments and other technical documentation.
• Support technical transfer of product portfolio into the Ohio site.
• Drive productivity, throughput, and efficiency gains in packaging lines.
• Communicate milestones across the network to ensure alignment.
• Analyze, design, and implement manufacturing/process improvements.
• Author and manage deviation/CAPA/EV documents and change controls.
• Build networks with commercial and clinical operations.

Skills

Packaging equipment

CQV experience

Cross-functional leadership

Documentation

Equipment parameterization

Tools

GMP equipment

Devices and packaging tech

Job description

Senior Process Development Engineer – Packaging Equipment Onsite

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.

Key Functions & Outputs

• 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


• 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.


• Analyze, design, and implement manufacturing/business process improvements.


• Drive productivity, throughput, and efficiency gains.


• Able to author and manage various documents/protocols/reports


• Deviation/CAPA/EV Owner


• Change Control Owner


• Build networks with commercial and clinical operations.


• Provide support for equipment standardization, troubleshooting, and performance trending

Preferred 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 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.

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