Process Development Engineer

Job Description

Job Description

Job Title: Process Development Engineer Job Description

The Process Development Engineer will support commercial bulk drug substance operations within the Process Development Drug Substance Technology group. This role focuses on technology transfer, process validation, and ongoing support of large-scale biologics manufacturing, including plant start-up activities and process lifecycle management. The engineer will collaborate closely with cross-functional teams to ensure robust, compliant, and efficient bioprocessing operations while providing hands-on support on the manufacturing floor and contributing to regulatory and CMC activities.

Responsibilities

• Apply a fundamental understanding of upstream and/or downstream bioprocessing to support plant start-up activities, biologics technology transfer, and process validation for commercial drug substance manufacturing.
• Support manufacturing investigations by performing root cause analysis, defining and implementing corrective and preventive actions (CAPA), and managing deviations in a structured and compliant manner.
• Contribute to continuous process verification and process monitoring by analyzing process data, identifying trends, and recommending optimization strategies to improve robustness, yield, and consistency.
• Participate in complex investigations related to process performance, quality events, and equipment issues, and support product lifecycle management initiatives for commercial and late-stage biologics.
• Ensure safety and regulatory compliance of all process development and technology transfer activities by following established procedures, guidelines, and quality systems.
• Provide on-floor process support during manufacturing campaigns, including real-time troubleshooting, guidance on process parameters, and coordination with operations staff.
• Support regulatory filings, inspections, and other Chemistry, Manufacturing, and Controls (CMC) activities by contributing technical documentation, data analysis, and subject matter expertise.
• Collaborate cross-functionally with Manufacturing, Quality, MSAT, Process Development, and Regulatory Affairs to align on process strategies, resolve issues, and implement improvements.
• Utilize strong data analysis skills to interpret process performance, evaluate the impact of changes, and support decision-making for process development and commercial operations.

Essential Skills

• Demonstrated experience supporting commercial or late-stage biologics manufacturing, with a focus on large-scale operations rather than purely research environments.
• Direct experience with technology transfer of biologics processes into manufacturing facilities, including coordination of process knowledge, documentation, and training.
• Proven experience in process validation activities for biologics, including protocol development, execution, and data analysis.
• Experience investigating manufacturing deviations and leading CAPA activities, including root cause analysis and implementation of sustainable corrective actions.
• Strong data analysis skills, including the ability to interpret complex process data sets and derive meaningful conclusions for process performance and optimization.
• Experience with manufacturing investigations, deviation management, and support of continuous process verification and process monitoring programs.
• Fundamental understanding of upstream and/or downstream bioprocessing operations in a commercial bulk drug substance facility.
• Ability to work effectively in a cross-functional environment with Manufacturing, Quality, MSAT, Process Development, and Regulatory Affairs teams.
• Masters degree OR Bachelors degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.

Additional Skills & Qualifications

• Experience supporting greenfield or plant start-up activities, including introduction and scale-up of new biologics processes.
• Familiarity with continuous process verification concepts and implementation in commercial biologics manufacturing.
• Exposure to product lifecycle management activities for biologics, including process monitoring, optimization, and change management.
• Experience contributing to regulatory filings and inspections related to biologics manufacturing and CMC activities.
• Strong communication and collaboration skills to work effectively with technical and operational stakeholders.
• Ability to provide hands-on, on-floor process support and to operate effectively in a dynamic, production-focused environment.

Work Environment

The role is based within a Process Development Drug Substance Technology group that supports a commercial bulk drug substance facility. Work is performed 100% on-site, with a working schedule that follows a standard weekday pattern and includes the potential for overtime as operational needs arise. The environment is highly collaborative, requiring close interaction with Manufacturing, Quality, MSAT, Process Development, and Regulatory Affairs teams. The position involves regular presence on the manufacturing floor to provide process support, participate in investigations, and oversee technology transfer and validation activities in a large-scale biologics setting.

Job Type & Location

This is a Contract position based out of Holly Springs, NC.

Pay and Benefits

The pay range for this position is $47.00 - $58.00/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)

Job Type & Location

This is a Contract position based out of Holly Springs, NC.

Application Deadline

This position is anticipated to close on Oct 27, 2026.

Workplace Type

This is a fully onsite position in Holly Springs,NC.

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.