Process Development Engineer

Process Development Engineer

Due to our continued growth, Corium Innovations is seeking a Process Development Engineer to develop and implement manufacturing processes from concept through production in a cGMP environment. This includes the planning and execution of development and clinical trials, as well as the documentation of these trials in technical reports. In addition, this position provides technical support to existing commercial operations including but not limited to process troubleshooting, investigations, and continuous improvement initiatives. Your most innovative career move is here! At Corium Innovations, we've led the way in innovating drug delivery technologies for millions of patients whose GI systems just can't tolerate pills, who can't remember to take their meds as directed, or who have needle-phobia. This is only the beginning! There's so much more to deliver, and we need YOU to do it! Our purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients. Our goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution. Our company values are core to our positive and people-centric culture which inspires all of us to come to work every day on behalf of our people, our partners, our customers, and our patients. Through our four core values, we put people first and create opportunities to make each day better than the last.

Celebrate Individuals: We're looking for talent who will celebrate the uniqueness of each of our team members by encouraging everyone to bring their authentic self to work.

Successful Together: We believe we're better together, so we prioritize teamwork as we work to achieve our shared vision knowing each one of us has an important role to play.

Embrace Innovation: We embrace new challenges and opportunities while encouraging creative thinking and innovative solutions to best meet the needs of our people and our partners.

Pride in Ownership: We take pride in owning our progress and successes, feeling empowered to pursue our growth to reach our full potential. And we hope you will too!

Responsibilities:

• Plan process development trials through the writing of development plans and sourcing of material and equipment.
• Summarize trial results in technical summary reports.
• Execute, coordinate, and document process experiments and clinical production on 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 the project team and the customer.
• Conduct technical investigations of manufacturing and laboratory deviations using a variety of root cause analysis techniques. This includes leading a cross-functional team to investigate and document findings, establish timelines, and implement corrective actions 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 support of customer and agency audits.

Qualifications:

• Bachelor's degree or higher in Chemical Engineering, Mechanical Engineering, or a related field.
• A minimum of 3 years of experience in a pharmaceutical and/or consumer goods manufacturing environment (minimum of 1 year of experience for candidates with a Master's degree or PhD).
• Previous GMP/FDA experience.
• Previous experience in the areas of adhesive systems, mixing, coating, extrusion, converting, and/or packaging operations.
• Team player.
• Motivated and results oriented.
• Skilled in problem analysis and problem resolution.
• Good interpersonal and communication skills.

Benefits:

• Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program.
• 401(k) retirement savings account with a company match and immediate vesting.
• 12 paid holidays.
• Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.