Corium Innovations · 1 day ago
Validation Engineer
Grand Rapids, MI
Full-time
Onsite
Mid, Senior Level
5+ years expCorium 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 position involves performing validation/qualification activities and collaborating with other departments to ensure compliance with corporate objectives.
Health CareMedicalPharmaceutical
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
Qualification
Required
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
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
Preferred
Previous hands-on experience with equipment, facilities, utilities, lab instruments and computer system qualification (IQ/OQ/PQ), requirements documents, impact assessments, and summary reports
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
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.
Company
Corium Innovations
Corium Innovations developes and produces novel drug delivery technologies.
51-200 employees
H1B Sponsorship
Corium Innovations has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$100MKey Investors
Webster Equity Partners
2022-10-20Private Equity· $100M
2018-11-27Acquired
Leadership Team
Mark Sirgo
Chief Executive Officer
Ellen Shaffer, SPHR
Associate Director, HR Business Partner
Recent News
BioWorld Financial Watch
2025-07-29
2025-04-02
2025-04-02
Company data provided by crunchbase