Senior Process Engineer II - OSD and Packaging

Role Summary

Senior Process Engineer II - OSD and Packaging at Takeda's Lexington, MA site. You will contribute to the design, start-up, operation, and optimization of oral solid dosage and packaging manufacturing equipment, supporting design-build projects and ongoing commercial manufacturing. You will serve as a technical subject matter expert for manufacturing unit operations, ensuring safe, compliant, and reliable production while driving process efficiency and continuous improvement. This role blends engineering and operations, involves hands-on problem solving on the shop floor, and requires close collaboration with equipment vendors, operators, and cross-functional peers to deliver tangible production impact.

Responsibilities

• Serve as a Process Engineering subject matter expert (SME), applying Good Engineering Practice (GEP) principles to the design, build, and testing of manufacturing unit operations within your scope. You will partner closely with Manufacturing, Manufacturing Sciences, Facilities, Global Engineering, Quality, and cross‑functional project teams.
• Lead and execute start‑up, commissioning, and validation activities for new equipment and processes supporting cGMP operations, including milling, sieving, IBC handling, roller compaction, fluid bed drying, tablet compression, coating, packaging, and CIP/COP systems.
• Support day‑to‑day manufacturing operations by maintaining and continuously improving equipment performance and reliability, serving as the primary technical point of contact for your assigned area.
• Drive effective troubleshooting and root‑cause analysis, supporting deviation investigations, closure activities, and the implementation of corrective and preventive actions (CAPAs).
• Develop, review, and sustain technical and GMP documentation, including SOPs, specifications, and engineering assessments, ensuring alignment with global standards and regulatory expectations.

Qualifications

• Proven experience supporting oral solid dosage manufacturing equipment, including milling, blending, granulation, drying, compression, coating, and packaging (strongly preferred).
• Strong technical problem‑solving capability, with the ability to lead cross‑functional troubleshooting efforts and drive successful project execution.
• Hands‑on experience working in cGMP pharmaceutical or other regulated manufacturing environments.
• Demonstrated ownership of equipment performance, with a track record of driving continuous improvement and serving as a trusted technical subject matter expert.
• Excellent communication and collaboration skills, with the ability to effectively engage engineering, manufacturing, quality, and cross‑functional stakeholders at all levels of the organization.

Education

• Bachelor’s degree in Engineering (Chemical, Mechanical, Process, or related discipline) with a minimum of 10 years of relevant industry experience.

Additional Requirements

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Able to lift, push, pull and carry up to 25 lbs.
• Combination of sedentary work and walking around observing conditions in the facility.
• Able to work in controlled or clean room environments requiring special gowning.
• Pace will be fast, able to prioritize multiple tasks from multiple customers.
• Able to work more than 8 hours a day or 40 hours a workweek as required.
• May participate in process engineering on-call program
• May require availability outside regular business hours.