Process Engineer

Work Location: Indianapolis, Indiana
Shift: No
Department: LS-SC-POEMA Clinical Tech Services
Recruiter: Katherine Hall

Hiring Manager: Stan Le
This information is for internals only. Please do not share outside of the organization.

Your Role:

• Provide key engineering support and project coordination for all phases of plant operations, including interfacing with internal and external clients for product technology transfers and manufacturing.
• Offer technical support for processes and product investigations, and continuously improve manufacturing processes, including technical transfer and scale-up of new product introductions.
• Become a Subject Matter Expert (SME) for multiple product lines (preclinical through commercial) by applying extensive process knowledge and experience.
• Coordinate and execute technology transfer projects for new clinical and commercial products and contract manufacturing opportunities, serving as the main technical interface with external/internal clients.
• Manage project deliverables by coordinating with multiple internal and external departments and executing small to medium-scale technical projects up to $250K in value.
• Perform process and equipment design engineering, including project estimating, budgeting, developing capital appropriation requests, documentation updates, scheduling, and overall project coordination.
• Provide project and process engineering support for technical projects, including equipment specification and procurement, process and drawing development, and protocol development/execution.
• Develop and modify engineering drawings, SOPs, control loops/strategies, and perform calculations (hydraulic, heat transfer, material balances), while also leading and executing validation protocols (IQ, OQ, PQ) for various systems.

Physical Attributes:

• Climb stairs and ladders.

Who You Are:

Minimum Qualifications:

• Bachelors Degree in Biology, Microbiology, Biochemical Engineering, Chemical Engineering, or other Life Science or Engineering discipline and 2+ years of work experience with US and European GMP requirements, FDA guidelines, and industry validation expectations.

OR

• Masters Degree in Biology, Microbiology, Biochemical Engineering, Chemical Engineering, or other Life Science or Engineering discipline and 1+ years of work experience with US and European GMP requirements, FDA guidelines, and industry validation expectations.

Preferred Qualifications:

• Experience with aseptic manufacturing processes and packaging equipment, unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process hazards and safety.
• Experience with Microsoft Office Suite.
• Experience with AutoCAD, Minitab, or JMP.

• Experience with Root Cause Analysis methodology, FMEA or another program.

RSREMD

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.