Process Engineer
Location: Onsite in Wilson, NC
Duration: Long-Term Contract (Potential for Extension and/or Conversion)
Rate: 55-80/hr
Overview
We are seeking a Process Engineer to support manufacturing operations focused on improving production efficiency, process reliability, product quality, and regulatory compliance. This individual will work cross-functionally with Manufacturing, Quality, Validation, Automation, and Engineering teams to optimize manufacturing processes while ensuring compliance with FDA, GMP, and company standards.
Responsibilities
- Analyze existing manufacturing processes and identify opportunities to improve throughput, quality, and reduce manufacturing costs.
- Lead continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
- Develop, execute, and document process validations (IQ/OQ/PQ).
- Investigate manufacturing deviations, non-conformances, and CAPAs using root cause analysis tools.
- Support equipment commissioning, qualification, and startup activities.
- Create and revise SOPs, work instructions, process flow diagrams, PFMEAs, and engineering documentation.
- Collaborate with Manufacturing, Quality, Validation, Automation, Maintenance, and Supply Chain teams to implement process improvements.
- Utilize statistical analysis and process monitoring tools to improve process capability and manufacturing performance.
- Support change control activities while ensuring compliance with GMP, FDA, and internal quality standards.
- Assist with new product introductions (NPI), technology transfers, and process scale-up activities.
- Participate in risk assessments, production troubleshooting, and manufacturing readiness reviews.
Required Qualifications
- Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Industrial Engineering, Manufacturing Engineering, or a related engineering discipline.
- 2+ years of Process Engineering experience within a regulated manufacturing environment.
- Experience supporting pharmaceutical, biotechnology, medical device, life sciences, or other highly regulated manufacturing operations.
- Working knowledge of GMP, FDA regulations, and quality systems.
- Experience performing process validation (IQ/OQ/PQ).
- Experience supporting deviation investigations, CAPAs, and root cause analysis.
- Strong understanding of manufacturing process optimization and continuous improvement.
- Excellent analytical, troubleshooting, and cross-functional communication skills.
Preferred Qualifications
- Lean Manufacturing certification.
- Six Sigma Green Belt or Black Belt.
- Experience with Statistical Process Control (SPC) and Minitab.
- Experience supporting automation systems (PLC, SCADA, DeltaV, Rockwell, Siemens, etc.).
- Familiarity with MES and ERP systems (SAP preferred).
- Experience supporting cleanroom or sterile manufacturing environments.
Technical Skills
- Process Engineering
- Lean Manufacturing
- Six Sigma
- GMP / FDA Compliance
- Process Validation (IQ/OQ/PQ)
- CAPA
- Root Cause Analysis (5 Whys, Fishbone)
- Statistical Process Control (SPC)
- Minitab
- Process Flow Mapping
- PFMEA
- SOP Development
- Change Control
- Risk Assessment
- Manufacturing Process Optimization
- MES
- SAP (Preferred)
Preferred Industry Background
Candidates with experience in:
- Pharmaceutical Manufacturing
- Medical Device Manufacturing
- Biotechnology
- Cell & Gene Therapy
- Biologics
- Sterile Manufacturing
- Fill/Finish Operations
- Packaging Operations
- Continuous Manufacturing
- Validation Engineering
- Automation & Controls
- New Product Introduction (NPI)
Disclaimer: Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.
EEO:
We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.
Benefits & Perks:
Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
Pay: $55.00 - $80.00 per hour
Benefits:
- Health insurance
- Vision insurance
Work Location: In person
