Lead Process Engineer-Equipment

Company Name: Alkermes

Position Summary

The Lead Process Equipment Engineer is accountable for driving optimal equipment design, strategic reliability practices, and continuous improvement initiatives to consistently exceed customer expectations. Serves as the SME on process equipment and demonstrates deep functional knowledge of equipment operation across polymer, sterile, and oral solid dosage (OSD) pharmaceutical processes. Spearheads and contributes to continuous improvement projects aligned with commercial and clinical production needs. The role requires troubleshooting automated equipment, implementing equipment improvements, and ensuring compliance with regulatory documentation and operational protocols. This position will collaborate cross-functionally with teams such as, Engineering, Reliability, Manufacturing and Quality to strengthen equipment reliability and proactively mitigate supply chain risk.

Job Description

• 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.

Knowledge/Skills Needed

• 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.

Personal Attributes Needed

• 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.

Physical Requirements

• 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 operate all types of production equipment.
• 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.

Education and Experience

Engineer II

Basic Qualifications

• BS degree in Engineering or technical discipline.
• 6+ years of manufacturing experience or technical experience.

Preferred Qualification

• 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.

Lead Engineer I/II

Basic Qualifications

• BS degree in Engineering or technical discipline.
• 8+ years of manufacturing experience or technical experience.

Preferred Qualification

• 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.

Travel

Travel domestic and international (<10%)