Process Engineer- Life Sciences

Who You’ll Work With
You will join one of our 45 offices in the US, be part of a committed team of over 1600 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.
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.
What You’ll Do
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 (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:

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.

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)

Purification:

Responsible as a System Owner of Purification systems and processing operations. Provide technical support to chromatography, filtration, concentration, viral clearance, and bulk drug substance processing systems. Response 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

cGMP & Regulatory Compliance: 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.

Blood Fractionation:

Responsible as a System Owner of Blood Fractionation systems and processing operations. Provide technical support for plasma fractionation processes used in production of plasma-derived therapies. Response 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. 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.
cGMP & Regulatory Compliance: 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.

What You’ll Bring

• 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 required.

• 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).

• Willing and able to travel as necessary for project requirements to include but not be limited to: project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.

• BS degree in Chemical, Mechanical or Bio Engineering is preferred but consideration will be given to other engineering degrees based on actual project experience.
  

Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Process Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

The approximate pay range for this position is $90,000 - $130,000 per year. Please note that the pay range provided is a good faith estimate for the position at the time of posting. In addition to base compensation, this position is eligible for variable compensation based on individual and/or company performance, in accordance with the terms of the applicable plan. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.

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