Corium Innovations is seeking a Validation Engineer II/Sr. Validation Engineer who will be responsible for the maintenance and execution of the site validation programs including equipment, facilities, utilities, lab instrumentation and computer systems. This includes successfully working with other departments, contract resources, and customers/vendors (as applicable) to plan, develop, maintain and execute validation and qualification activities. This position will also be involved with site audit activities, investigations, change management evaluation and qualified utility ownership. The Sr. Validation Engineer is responsible for performing appropriate validation/qualification activities (IQ/OQ/PQ) and other system support activities to meet department, site and corporate objectives. This position involves the review and reporting of data, annual review and routine qualification/verification activities required for all systems.
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:
- Development of validation or qualification deliverables, performing testing, verification, calibration, and routine maintenance of equipment, facilities, utilities, lab instruments and computer systems.
- Develop and maintain procedures for qualification utilizing known industry best practices.
- Utility and functional area reporting.
- Quality system interaction (investigation, CAPA, change control)
- Asset Management System ownership and maintenance
- Continuous Improvement and other special projects in the Engineering Services functional area.
Qualifications:
- Bachelor’s degree in a STEM field.
- 5+ Years’ experience in the pharmaceutical industry.
- Strong knowledge of FDA/cGMP/ISO requirements.
- Knowledge of GMP Quality Systems and working knowledge of regulatory requirements.
- Previous hands-on experience with equipment, facilities, utilities, lab instruments and computer system qualification (IQ/OQ/PQ), requirements documents, impact assessments, and summary reports preferred.
- Previous hands-on experience with lab instrumentation and calibration, including but not limited to HPLC/UHPLC, GC, Dissolution Baths.
- Cleanroom and qualified utility monitoring and qualification experience preferred.
- Demonstrated analytical skill/problem solving skills.
- Must have good organizational skills, able to multi-task, and be capable of adjusting to changing priorities.
- Self-starter
- Excellent interpersonal and communication skills, both written and verbal.
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.
