Alkermes · 2 months ago
Process Engineer II/Lead-OSD
Cincinnati Metro
Full-time
Hybrid
Mid, Senior Level
2+ years expAlkermes is a global biopharmaceutical company focused on developing medicines for complex psychiatric and neurological disorders. The Process Engineer II/Lead-OSD will support manufacturing operations, scale-up processes, troubleshoot equipment, and ensure compliance with regulatory standards while implementing improvements in production efficiency.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Troubleshoot and maintain manufacturing systems, processes, and equipment
Support the development or transfer of manufacturing and cleaning processes for the manufacturing area
"Hands-on" ability to install and troubleshoot instrumentation and equipment
Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
Specify and size manufacturing systems, equipment, and process equipment
Qualification
Required
BS degree in Engineering or technical discipline
2-5 year of manufacturing experience or technical experience
Troubleshoot and maintain manufacturing systems, processes, and equipment
Support the development or transfer of manufacturing and cleaning processes for the manufacturing area
"Hands-on" ability to install and troubleshoot instrumentation and equipment
Author high-quality technical protocols/reports (engineering studies, summary reports, equipment specifications, change controls, and investigations)
Specify and size manufacturing systems, equipment, and process equipment
Excellent communication and documentation skills
Excellent organizational skills
Ability to self-manage and prioritize workload
Ability to react quickly to understand and solve problems
Excellent troubleshooting skills
Fosters collaborative relationships within and across groups through influencing and negotiation skills
Positive attitude
Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time
Ability to lift/move 40 lbs. overhead. Ability to team lift up to 100 lbs
Must be able to be medically cleared for respirator use (PAPR)
Ability to operate different types of production equipment
Ability to gown correctly for clean room manufacturing operations
Ability to stand or sit for extended periods (up to 2 hours at a time)
Must be able to work in an office and a manufacturing environment
Preferred
2-5 years of OSD pharmaceutical experience or 5 years of pharmaceutical engineering experience
Experience with OSD equipment procurement
Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations
Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up
Knowledge of OSD pharmaceutical process and equipment validations
Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc
5+ years of OSD pharmaceutical experience
Experience with OSD equipment procurement
Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations
Thorough knowledge of OSD operations, statistics, equipment design, process control, and process scale-up
Knowledge of OSD pharmaceutical process and equipment validations
Experience in statistical analysis: sample sizing, ANOVA, regression analysis, control charts, etc
Benefits
Certified as a Great Place to Work in the U.S. in 2024
Honored as a Healthiest Employer in both Ohio and Massachusetts in 2023
A Best Place for Working Parents in 2023
Received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023)
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes 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
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-06
Company data provided by crunchbase