Process Development Engineer

Corium Innovations • Grand Rapids, MI

1d

About The Position

Corium Innovations is seeking a Process Development Engineer to develop and implement manufacturing processes from concept through production in a cGMP environment. The role plans and executes development and clinical trials and documents their outcomes in technical reports. It also provides technical support to existing commercial operations through process troubleshooting, investigations, and continuous improvement initiatives.

The position supports new product start-ups and ongoing commercial production, works with pilot- and commercial-scale equipment, and collaborates with cross-functional project teams and customers. It also supports regulatory submissions and customer and agency audits.

Requirements

• Bachelor’s degree or higher in Chemical Engineering, Mechanical Engineering, or a related field.
• At least 3 years of experience in a pharmaceutical and/or consumer goods manufacturing environment, or at least 1 year for candidates with a Master’s degree or PhD.
• Previous GMP/FDA experience.
• Team player.
• Motivated and results oriented.
• Skilled in problem analysis and problem resolution.
• Good interpersonal and communication skills.

Nice To Haves

• Previous experience in adhesive systems, mixing, coating, extrusion, converting, and/or packaging operations.

Responsibilities

• Plan process development trials by writing development plans and sourcing materials and equipment.
• Summarize trial results in technical summary reports.
• Execute, coordinate, and document process experiments and clinical production using pilot- and commercial-scale equipment.
• Create, revise, and approve batch records, work instructions, and other quality system documents.
• Provide development support for new product start-ups and ongoing commercial production, including troubleshooting equipment and manufacturing problems.
• Communicate project status and technical findings to project teams and customers.
• Conduct technical investigations of manufacturing and laboratory deviations using root cause analysis techniques.
• Lead cross-functional investigations, document findings, establish timelines, and implement corrective actions according to plan.
• Support, initiate, and approve engineering change requests, deviations, and corrective actions related to assigned products.
• Lead continuous improvement projects.
• Support regulatory submission activities, including customer and agency audits.

Benefits

• Medical, dental, and vision insurance.
• Flexible spending accounts.
• Life insurance and disability insurance.
• Employee assistance program.
• 401(k) retirement savings account with company match and immediate vesting.
• 12 paid holidays.
• Competitive paid vacation plan.
• Approximately one additional week of paid time off for the annual holiday shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level