Job Description
Job Description
Job Title: Process Engineer
Job Description
As a Process Engineer, you will be responsible for the startup, troubleshooting, and planning, executing, and documenting validation activities for a multi-layer cast extrusion line. You will ensure compliance with regulatory standards and internal quality requirements and play a critical role in supporting the development, training, and hand-off of extrusion equipment to the laboratory.
Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for laboratory instruments, equipment, and systems.
- Collaborate with cross-functional teams to ensure validation activities align with project timelines and regulatory expectations.
- Author and review validation documentation including risk assessments, validation plans, reports, and SOPs.
- Ensure compliance with regulatory requirements such as GxP guidelines.
- Maintain validation lifecycle documentation and change control records.
- Participate in continuous improvement initiatives to enhance validation processes and efficiency.
- Identify and resolve issues related to equipment functionality during validation processes.
- Provide guidance and training to laboratory staff on validation procedures and equipment use.
- Develop or update SOPs, work instructions, and process control plans.
- Define critical quality attributes (CQA) and critical process parameters (CPP).
- Train quality technicians on inspection methods specific to the new line.
- Ensure traceability and documentation meet regulatory or customer requirements.
- Train operators on machine operation, startup/shutdown, troubleshooting, and safety.
- Train staff on safe operation and emergency procedures.
- Provide maintenance with preventive maintenance schedules and spare-parts lists.
- Create troubleshooting guides and support initial production runs until the line is stable and operators are confident.
Essential Skills
- Strong documentation and communication skills.
- Understanding of regulatory and quality requirements and common validation procedures.
- Safety and compliance-oriented mindset.
- 10+ years of relevant experience in extrusion including validation within a scientific or regulated industry.
- Strong understanding of regulatory requirements (GxP).
- Previous experience in equipment validation, particularly IQ/OQ/PQ processes, within a regulated environment (e.g., pharmaceutical, biotech).
- Excellent technical writing, documentation, and communication skills.
- Proficiency in Microsoft Office and validation management systems.
- Ability to manage multiple projects and priorities in a fast-paced environment.
Job Type & Location
This is a Contract position based out of Buffalo Grove, IL.
Pay and Benefits
The pay range for this position is $50.00 - $60.00/hr.
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 Buffalo Grove,IL.
Application Deadline
This position is anticipated to close on Mar 16, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.