Engineer - TS/MS Device Assembly & Packaging, DPEM

Role Summary

Engineer - TS/MS Device Assembly & Packaging, DPEM. Responsible for all technical activities related to the support of external manufacturing, with a focus on Device Assembling and Packaging, as part of the Technical Service Manufacturing Science function within DPEM. Acts as the process expert for contract manufacturing relationships and provides oversight of day-to-day operations and the technical agenda at the contract manufacturers.

Responsibilities

• Support On-Going CM Operations by providing technical oversight at the Joint Process Team as Primary Loop support
• Become the process expert for process steps or processing equipment within the scope of the process team, including understanding the science of the process, owning the process control strategy, knowing the product development/validation history, and documenting work in Process Flow Diagrams
• Ensure the process is maintained in a validated / capable state, including sterilization and Bioburden control strategies, PQ activities, and overseeing documentation at CMs
• Maintain accurate process flow diagrams describing process, control strategy, parameters, and CQAs; monitor ongoing validation state; complete APRs and OPV with defined actions
• Assist Quality and Supply Chain in SCR, Quality Agreements, and MRDs; assist CMs with audits and regulatory interactions
• Provide daily operations support: use statistical tools to reduce variability, extract relevant parameters, lead root cause analyses, own deviations/ CAPAs/ changes, assist with batch records, and liaise with subject-matter experts
• Own process capability and yield improvements; analyze process for vulnerabilities and drive continuous improvement
• Collaborate with External Manufacturers to maintain awareness of operations and ensure timely technical agenda and training as needed
• Participate in Technical Transfer Projects; supervise PQ, validation, and manufacturing readiness; support Process Validation batches and finalize reports; communicate project status and root causes timely
• Contribute to Department Initiatives and participate in Joint Process Team objectives; provide input in monthly reports and metrics; pursue continuous improvement; model safety behaviors

Qualifications

• Required: Bachelor's Degree in Engineering (strongly preferred), Chemistry, Pharmacy or similar STEM field
• Required: 1+ year experience in pharmaceutical or medical device manufacturing (process engineering experience preferred)

Skills

• Understanding of cGMPs and drug product manufacturing
• Strong communication, attention to detail in procedures and protocol development
• Technical curiosity and critical thinking; high learning agility
• Leadership, interpersonal and teamwork abilities; comfortable working in a team
• Data-driven decision making; willingness to learn new technologies; ability to work in virtual/complex environments
• Willingness to travel; appreciation for cultural diversity
• Device assembly and/or packaging experience; knowledge of basic statistical tools
• Regulatory experience; equipment, utility, and facility qualification experience
• Established technical and internal networks; experience supporting packaging, dry, and/or parenteral manufacturing

Education

• Bachelors Degree in Engineering (strongly preferred), Chemistry, Pharmacy or similar STEM related fields

Additional Requirements

• Shift is days; off hours may be necessary to support operations
• Travel up to 30% is possible
• Onsite in Indianapolis, IN with allowance to work from home up to four days per month