Process Engineer- Life Sciences

Job Description

When you join Design Group as a Process Engineer (System Owner), you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world's leading companies solve their most difficult problems. You will partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

Design Group is looking for Engineers with 5-10 years' experience in one of the following processes:

• Aseptic Filling / Finish
• Purification
• 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 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, including supporting one of the following roles:

• 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 with in this industry can include filling system supporting equipment such as Parts Washer, Autoclaves, Stoppering Systems, Semi-Automated Inspection systems, and Clarified Bulk Tank systems.
• Participate in system design discussions and workshops with clients, design-build firms, and OEM.
• 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.
• cGMP & Regulatory Compliance:
  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).

• System Owner of Purification systems and processing operations.
• Provide technical support to chromatography, filtration, concentration, viral clearance, and bulk drug substance processing systems.
• Maintain 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 is required.