Process Engineer- Life Sciences

Barry-Wehmiller•Oakbrook, IL

1d•Hybrid

About The Position

Design Group is looking for Engineers with 5 -10 years’ experience in one of the following processes: Aseptic Filling / Finish, Purification, or Blood Fractionation. The Process Engineer role is a key member of the Life Science Team with responsibilities beginning with initial client contact, developing early stakeholder (client) alignment based on relationships built on technical competency, proactive client engagement and development of innovative solutions. You will serve as a consulting engineer and technical lead supporting pharmaceutical and biotech clients on your defined process as mentioned previously. The role will span the entire project lifecycle from basic and detailed design through procurement, construction, commissioning, and startup activities of the systems & equipment that you will be directly responsible for. In addition to working on these project lifecycle phases, you will be expected and responsible for performing technical activities, which would include supporting one of the following roles: Aseptic Filling / Finish, Purification, or Blood Fractionation.

Requirements

Minimum of 5 years of pharmaceutical and biologics process system engineering/design experience.
Engineering experience in aseptic fill/finish, purification, and/or blood fractionation processes.
Working knowledge of process definition means and methods including identifying process unit operations.
Experience with the previously listed regulatory standards and guidance.
Excellent communication skills, written and oral, interpersonal skills and ability to interact with our valued team members and clients.
Computer skills including AutoCAD (basic), Microsoft Office, and Microsoft Project (basic).
BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience.

Nice To Haves

Understanding of FDA (CFR) /EMA regulations (USP, Annex 1), FDA Guidance (Sterile Drug Products Produced by Aseptic Processing, Process Validation), ICH guidelines, ISO 13408 and 14644, PDA Technical Reports (29, 60, 64, and 90)
Understanding of FDA 21 CFR Parts 210 and 211, FDA Process Validation Guidance, ICH Guidelines ( Q7 through Q12), PDA Technical Reports on Filtration and Bioprocessing, ASME BPE Standards, USP and EU GMP Requirements.
Understanding of FDA 21 CFR Parts 210, 211, 600, and 640, EMA Guidance for Plasma-Derived Medicinal Products, FDA Process Validation Guidance, USP and EU GMP requirements, ICH Guidelines (Q8 through Q11), and ASME BPE standards.

Responsibilities

Serve as a consulting engineer and technical lead supporting pharmaceutical and biotech clients on their defined process.
Span the entire project lifecycle from basic and detailed design through procurement, construction, commissioning, and startup activities of the systems & equipment.
Perform technical activities supporting one of the following roles: Aseptic Filling / Finish, Purification, or Blood Fractionation.
Responsible as a System Owner of Aseptic Filling systems and processing operations, regulatory guidance trends, evolving technology innovations, OEM supplier community partner, with contributions from early design through commissioning and startup activities within the system lifecycle.
Experience within this industry can include filling system supporting equipment, such as Parts Washer, Autoclaves, Stoppering Systems, Semi-Automated Inspection systems, and Clarified Bulk Tank systems.
Ability to participate in system design discussions and workshops with clients, design-build firms, and OEM.
Ability to develop user requirement specifications, review equipment layouts, and work with OEM directly on design changes, procurement activities, commissioning, startup, and handover.
Collaborate with quality and CQV teams on equipment qualification, process validation, and regulatory readiness.
Provide technical support to chromatography, filtration, concentration, viral clearance, and bulk drug substance processing systems.
Responsible for maintaining expertise in regulatory expectations, process technologies, automation advancements, and OEM supplier capabilities while supporting a capital expansion project through each equipment’s lifecycle.
Prior experience supporting one or many of the following systems: Chromatography Systems, Protein Purification, TFF / UF/DF / Viral Filtration / Depth Filtration Systems, Viral Clearance and Filtration, Process and Buffer Tanks, Bulk Drug Storage Tanks, Single-Use Systems, CIP / SIP Systems, Protein Purification Processes.
Provide technical support for plasma fractionation processes used in production of plasma-derived therapies.
Responsible for maintaining expertise in regulatory expectations, process technologies, automation advancements, and OEM supplier capabilities while supporting a capital expansion project through each equipment’s lifecycle.
Prior experience supporting ethanol-based fractionation systems, precipitation tanks, filter presses, intermediate hold tanks, bulk transfer systems, and CIP/SIP systems.