Process Engineer

Job Description

Job Description

Job Title: Process Engineer Job Description

The Process Engineer plays a key technical role in the development, transfer, scale-up, validation, and continuous improvement of biologics manufacturing processes within a GMP-regulated environment. This position applies foundational scientific and engineering principles to support clinical and commercial production, ensuring processes are robust, compliant with regulatory standards, and aligned with Chemistry, Manufacturing, and Controls (CMC) expectations. The engineer collaborates closely with cross-functional teams to provide technological input, optimize chromatography and other unit operations, and maintain high-quality documentation and communication throughout the product lifecycle.

Responsibilities

• Apply general scientific and engineering principles to support the development, scale-up, validation, and transfer of biopharmaceutical manufacturing processes.
• Serve as a key technical contributor in the transfer and continuous improvement of biologics manufacturing processes, with a focus on chromatography operations.
• Collaborate with cross-functional teams to ensure successful clinical and commercial production while maintaining compliance with cGMP and regulatory requirements for US and EU markets.
• Provide technological input and recommendations to improve process robustness, efficiency, and scalability across upstream and downstream unit operations.
• Support the creation, review, and maintenance of technical documentation, including protocols, reports, and standard operating procedures, in accordance with GMP standards.
• Use Microsoft Word and Excel to prepare, analyze, and present process data, reports, and technical summaries.
• Contribute to process analysis activities and, where applicable, apply statistical methods to evaluate process performance and variability.
• Participate in troubleshooting and root cause investigations related to manufacturing processes, proposing and implementing corrective and preventive actions.
• Collaborate effectively with internal stakeholders, including engineering, manufacturing, quality, and regulatory teams, to align process strategies with CMC principles.
• Work independently on assigned technical tasks while also contributing as an active member of cross-functional project teams.
• Support knowledge transfer by sharing technical insights and, when applicable, mentoring junior engineers or technicians in process-related activities.
• Ensure adherence to GMP documentation practices and maintain accurate, clear, and timely records of all process-related activities.

Essential Skills

• Bachelor’s degree in Chemical Engineering, Biochemistry, or a related scientific field.
• Minimum of 3 years of experience in GMP-regulated biologics or pharmaceutical manufacturing.
• Strong understanding of current Good Manufacturing Practice (cGMP) and regulatory requirements for US and EU markets.
• Hands-on experience in process engineering within biopharmaceutical or pharmaceutical environments.
• Practical experience or strong interest in chromatography, with the ability to perform chromatography work and receive additional training as needed.
• Proficiency in Microsoft Word and Excel for documentation, data analysis, and reporting.
• Excellent communication skills, with the ability to clearly convey technical information to diverse stakeholders.
• Strong documentation skills, with attention to detail and adherence to GMP record-keeping standards.
• Ability to work independently with minimal supervision while effectively contributing to cross-functional teams.
• Familiarity with statistical methods for process analysis, with the ability to apply these tools to assess process performance.

Additional Skills & Qualifications

• Experience with upstream processing operations in biologics manufacturing.
• Experience with downstream processing operations, including purification steps such as chromatography.
• Knowledge of Chemistry, Manufacturing, and Controls (CMC) principles and their application to biologics development and manufacturing.
• Experience mentoring or providing guidance to junior engineers or technicians in a technical setting.
• Ability to learn and adapt to new process technologies and equipment used in biopharmaceutical manufacturing.
• Strong collaborative mindset and ability to build effective working relationships across engineering, manufacturing, quality, and regulatory functions.

Work Environment

The role is based in a GMP-regulated biopharmaceutical manufacturing environment that includes ISO-classified cleanroom spaces. The Process Engineer gowns into ISO spaces regularly, typically at least once per week, and follows established cleanroom protocols. This includes removing items such as earrings, cosmetics, and certain hair products prior to entry to maintain contamination control and meet strict environmental standards. Work involves close interaction with manufacturing operations, process equipment, and chromatography systems, with a strong emphasis on safety, quality, and adherence to documented procedures. The environment is highly regulated, structured, and collaborative, requiring consistent attention to detail, compliance with gowning and hygiene requirements, and clear communication across technical and operational teams.

Job Type & Location

This is a Contract to Hire position based out of Saint Louis, MO.

Pay and Benefits

The pay range for this position is $39.00 - $47.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Saint Louis,MO.

Application Deadline

This position is anticipated to close on Sep 15, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on us.fitly.work for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.