Senior Process Engineer

Arcadis; Cary (NC); On-site; USD 120,000 - 185,000; Full time

Job summary

Join a forward-thinking company as a Senior Process Engineer, where you'll play a pivotal role in the expansion of a brownfield biotech facility. This position involves collaborating with cross-functional teams to ensure the successful implementation and qualification of complex manufacturing systems. You'll engage with clients and manage technical expectations while troubleshooting and resolving process-related challenges. If you're passionate about delivering sustainable solutions and making a meaningful impact in the life sciences sector, this opportunity is perfect for you. Be part of a team dedicated to improving quality of life and creating a lasting legacy.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

Disability insurance

Paid parental leave

Reward & recognition program

Wellbeing benefits

Qualifications

• 10-15 years of experience in pharmaceutical manufacturing.
• Hands-on experience with upstream and downstream processing equipment.

Responsibilities

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

Skills

GMP Lifesciences

Biochemical Engineering

Troubleshooting

Problem-solving

Collaboration

Education

Bachelor's degree in Biochemical Engineering

Tools

Bioreactors

Chromatography Skids

Depth Filtration

TFF

UF/DF

Job description

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Direct message the job poster from Arcadis

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.

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 play a key part in developing the technical deliverables associated with the detailed design, CM, through commissioning start up lifecycle phases for all upstream and downstream manufacturing systems. The ideal candidate will work closely with Engineering, Manufacturing, Facilities, Quality, and Validation teams to ensure that equipment, systems, and processes are successfully implemented, qualified, and maintained for operational readiness.

• Act as a technical SME point of contact for upstream and downstream manufacturing system related queries from A/E firm and client.
• Act as an interface for Technical / Process aspects of the project with Engineering and Procurement (EP) Services provider during the Engineering phase of the project.
• Define client’s Process Technical expectations to EP Service provider and ensure delivery is in line with this expectation, including the application of standards and guidelines.
• The Process Engineer will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
• Engage with client Process End Users and SMEs to define process, product & facility technical aspects for the project in support of successful project delivery.
• Reviews design drawings, P&IDs (Piping & Instrumentation Diagrams), and system layouts
• Manage contractors and equipment vendors to ensure all aspects of the project are completed to specification, on schedule and according to budget
• Identify and control project risks using appropriate risk management tools and engagement in contingency planning.
• Perform hands-on activities that support process engineering from drafting procedures to execution of commissioning start up studies.
• Troubleshoot process-related deviations, failures, and inefficiencies
• Provide engineering support for the installation, commissioning, and qualification (CQV) of bioreactors, chromatography skids, filtration systems, and support utilities.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning activities.
• Work closely with project engineers, contractors, and vendors to execute system upgrades within the constraints of an active facility.
• Support change control processes for process modifications and equipment upgrades.
• Facilitates punch list resolution and post-installation support.
• Partner with EH&S teams to ensure compliance with environmental regulations and safety best practices.
• Ensures systems meet operational requirements before handover to Manufacturing and Maintenance teams.

Qualifications & Experience:

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

Why Arcadis?

We can only achieve our goals when everyone is empowered to be their best. We believe everyone's contribution matters. It’s why we are pioneering a skills-based approach, where you can harness your unique experience and expertise to carve your career path and maximize the impact we can make together.

You’ll do meaningful work, and no matter what role, you’ll be helping to deliver sustainable solutions for a more prosperous planet. Make your mark, on your career, your colleagues, your clients, your life and the world around you.

Together, we can create a lasting legacy.

Join Arcadis. Create a Legacy.

Our Commitment to Equality, Diversity, Inclusion & Belonging

We want you to be able to bring your best self to work every day which is why we take equality and inclusion seriously and hold ourselves to account for our actions. Our ambition is to be an employer of choice and provide a great place to work for all our people. We are an equal opportunity and affirmative action employer. Women, minorities, people with disabilities and veterans are strongly encouraged to apply. We are dedicated to a policy of non-discrimination in employment on any basis including race, creed, color, religion, national origin, sex, age, disability, marital status, sexual orientation, gender identity, citizenship status, disability, veteran status, or any other basis prohibited by law.

Arcadis offers benefits for full time and part time positions. These benefits include medical, dental, and vision, EAP, 401K, STD, LTD, AD&D, life insurance, paid parental leave, reward & recognition program and optional benefits including wellbeing benefits, adoption assistance and tuition reimbursement. We offer nine paid holidays and 15 days PTO that accrue per year. Salaries will vary and are based on several factors, such as experience, education, budget, internal equity, project and location.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Design and Engineering

• Industries

  Professional Services, Design Services, and Engineering Services

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Tuition assistance

Disability insurance

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