Capital Project Senior Process Engineer

DPS Group Global; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Capital Project Senior Process Engineer to lead the expansion of a biotech facility. This pivotal role involves collaborating with various teams to ensure the successful implementation of manufacturing systems. You'll engage in all engineering phases, from conceptual design to qualification, while managing project risks and ensuring compliance with safety standards. Join a diverse and inclusive workplace that values every contribution and offers a comprehensive benefits package, including medical, dental, and 401K. This is an exciting opportunity to make a significant impact in the biotech sector.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401K

Paid Leave

Qualifications

• Bachelor’s degree in a relevant field with extensive experience in GMP Lifesciences.
• Hands-on experience with upstream/downstream processing equipment.

Responsibilities

• Act as a technical SME for manufacturing system queries.
• Manage contractors and vendors to meet specifications and budget.

Skills

Process Engineering

Troubleshooting

Problem-Solving

GMP Compliance

Technical Documentation

Education

Bachelor’s degree in Biochemical Engineering

10-15+ years in GMP Lifesciences

Tools

Bioreactors

Chromatography Skids

Filtration Systems

Job description

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About The Job

Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets.

We are more than 36,000 people, in over 70 countries, dedicated to improving quality of life. Everyone has an important role to play. With the power of many curious minds, together we can solve the world’s most complex challenges and deliver more impact together.

Role description: Arcadis is seeking a Capital Project Senior Process Engineer to support a brownfield biotech facility expansion focused on cGMP bulk drug substance manufacturing. This role will develop technical deliverables for detailed design, construction management, and commissioning start-up phases for upstream and downstream manufacturing systems. The candidate will collaborate with Engineering, Manufacturing, Facilities, Quality, and Validation teams to ensure successful implementation, qualification, and operational readiness of equipment, systems, and processes.

Role accountability

• Act as a technical SME for upstream and downstream manufacturing system queries from A/E firm and client.
• Interface for process and technical aspects with Engineering and Procurement during the engineering phase.
• Define client’s process technical expectations and ensure delivery aligns with standards and guidelines.
• Participate in all engineering project phases related to process equipment, from conceptual design to qualification.
• Engage with client process end users and SMEs to define technical aspects supporting project delivery.
• Review design drawings, P&IDs, and system layouts.
• Manage contractors and vendors to meet specifications, schedule, and budget.
• Identify and manage project risks and contingency plans.
• Support hands-on process engineering activities, including commissioning and start-up studies.
• Troubleshoot process deviations and failures.
• Provide support for the installation, commissioning, and qualification of bioreactors, chromatography skids, filtration systems, and utilities.
• Assist with FAT, SAT, and commissioning activities.
• Collaborate with project teams to execute system upgrades within active facilities.
• Support change control processes for modifications and upgrades.
• Facilitate punch list resolution and post-installation support.
• Partner with EH&S teams to ensure compliance with environmental and safety standards.
• Ensure systems meet operational requirements before handover to manufacturing and maintenance.

Qualifications & Experience:

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field with 10-15+ years in GMP Lifesciences/pharmaceutical manufacturing.
• Hands-on experience with upstream/downstream processing equipment, bioreactors, chromatography skids, filtration, TFF, UF/DF.
• Knowledge of biotech pharmaceutical manufacturing, aseptic processing, cell therapy, and process development.
• Strong troubleshooting and problem-solving skills for bioprocess deviations and equipment issues.
• Familiarity with GMP, cGMP, ISPE guidelines, and regulatory compliance.
• Ability to work in a fast-paced, cross-functional environment managing multiple priorities.
• Experience collaborating with facilities, operations, vendors, and engineering consultants.

Why Arcadis?

We believe everyone’s contribution matters and are committed to diversity, inclusion, and creating a great workplace. We offer benefits including medical, dental, vision, 401K, paid leave, and more. Salaries vary based on experience, education, and location.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Management and Manufacturing

Industries: Architecture and Planning