Alkermes · 9 hours ago
Lead Process Engineer-Equipment
Cincinnati Metro
Full-time
Onsite
Senior Level, Lead/Staff
6+ years expAlkermes is a fully-integrated, global biopharmaceutical company committed to developing medicines for complex psychiatric and neurological disorders. The Lead Process Equipment Engineer will drive optimal equipment design, lead continuous improvement initiatives, and collaborate with cross-functional teams to enhance equipment reliability and mitigate supply chain risks.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Andre Hums
Responsibilities
Serve as Equipment Owner for key manufacturing assets, driving strategic improvements, reliability initiatives, and capacity readiness to meet customer demand
Lead design, procurement, installation, startup, and commissioning of new process equipment
Troubleshoot automated equipment for pharmaceutical formulation and packaging
Partner with manufacturing and maintenance teams on repairs, preventive maintenance programs, and spare parts strategy
Conduct hands-on training and guidance for the operation of new equipment and processes
Author high-quality SOPs and technical documentation to maintain GMP compliance in collaboration with appropriate personnel
Develop and execute engineering studies, change controls, deviation investigations, and commissioning protocols
Perform risk assessments including FMEA to drive equipment reliability
Resolve deviations and ensure timely completion of corrective actions and audit responses
Champion site-level projects, improvement initiatives, and support operational excellence efforts
Ensure thorough and timely documentation (drawings, specifications, schedules, engineering studies, meeting minutes, etc.) and provide consistent updates to site leadership
Remain current on industry and FDA engineering standards and trends
Explore, evaluate, and recommend external technologies to improve current operations or introduce new capabilities
Qualification
Required
BS degree in Engineering or technical discipline
6+ years of manufacturing experience or technical experience
Advanced understanding of mechanical and chemical engineering principles applied to complex process systems and equipment
In-depth knowledge of automated control systems and integration into pharmaceutical manufacturing operations
Solid knowledge of computer systems and software applications supporting automation and data-driven decisions
Strong capabilities in process equipment design/specification, sizing, statistics, process control and operational risk analysis
Skilled in hands-on instrumentation installation and equipment troubleshooting
Proven ability to maintain and optimize manufacturing systems, utilities, and process equipment
Comprehensive knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations
In-depth knowledge of sterile pharmaceutical operations, process equipment and utility qualifications
Ability to author high-quality technical protocols/reports (Engineering Studies, Validation protocols, summary reports, equipment specifications, and SOPS)
Skilled in navigating matrixed cross-functional teams across engineering, quality, and operations
Strong presentation abilities with both technical and leadership audiences
Exceptional communication, coordination, and organizational skills
Ability to self-manage and prioritize workload
Ability to react quickly to understand and solve problems
Positive attitude and adaptable to changing priorities
Fosters collaborative relationships within and across and demonstrates ability to work within and contribute to highly effective teams
Skilled Engineer in design, installation, start-up, and commissioning of typical Pharmaceutical Mechanical Systems
Effectively manage conflict and differences of opinion
Ability to operate all types of production equipment
Occasional periods of repetitive motion
Ability to gown in an aseptic manner for clean room operations
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required
Ability to read, understand, and follow company SOP guidelines
Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed
Ability to stand in steel-toed shoes for a 2-3 hours at a time
Preferred
6+ years of Sterile pharmaceutical experience
Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations
Experienced working on (and coordinating) multiple projects in an orderly and efficient manner while consistently meeting established deadlines
Strong written and verbal communication skills. Ability to work successfully across functions to meet company objectives
Excellent troubleshooting and problem-solving skills
8+ years of Sterile pharmaceutical experience
Experienced working on (and coordinating) multiple projects in an orderly and efficient manner while consistently meeting established deadlines
Experienced working successfully across functions to meet company objectives
Benefits
Healthiest Employer in both Ohio and Massachusetts in 2023
Best Place for Working Parents in 2023
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 (23)
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
Genetic Engineering News
2025-12-24
2025-12-19
Company data provided by crunchbase