Process Engineer
Title: Process Engineer
Location: Quakertown, PA
Industry: Pharmaceutical
Salary: $65K
Schedule: Monday Friday Days
Employment Type: Direct Hire
Company Overview
Operating from a 100,000 square foot, US-based, state-of-the-art, FDA inspected facility, this company has the experience and capabilities to rapidly develop, scale up, and process APIs and excipients ranging from grams to multi-metric tons, including highly potent compounds.
Job Summary
The Process Engineer supports process scale-up, validation execution, and continuous improvement initiatives within a cGMP pharmaceutical manufacturing environment specializing in micronization and particle engineering. This role is responsible for drafting validation protocols, overseeing scale-up and validation runs, and authoring final validation reports. The Process Engineer (I) will also support the introduction of new processes and equipment, including procurement, qualification, testing, and modification activities to achieve defined technical and regulatory outcomes. This position requires strong cross-functional collaboration with SMEs in Facilities, QA, Operations, and Program Management to ensure safe, compliant, and efficient manufacturing operations.
Job Description - Draft and support IQ/OQ/PQ equipment qualification protocols and validation documentation in accordance with cGMP and company procedures.
- Assist with the technical evaluation of new processes transitioning from development to commercial scale.
- Support procurement of new manufacturing equipment (URS development, vendor qualification, FAT/SAT participation).
- Identify and implement equipment or process modifications to optimize performance and meet product specifications.
- Contribute to risk assessments (FMEA, hazard analysis) related to new process introduction.
- Assist in mechanical layout planning and equipment integration into existing facility infrastructure.
- Working closely with Facilities, QA, Program Managers and Operators, Coordinate and oversee engineering batches, scale-up runs, and process validation activities.
- Analyze process data to confirm process capability.
- Communicate technical findings clearly to internal stakeholders and clients.
- Author final validation summary reports with clear technical justification and regulatory defensibility.
- Support regulatory and client audits as required.
- Support cleaning validation activities and process optimization studies.
- Assist with process deviation investigations and support root cause analysis (RCA/CAPA).
- Contribute to engineering change control documentation.
- Support site EHS programs and assessments.
- Contribute to site hazardous waste program and air operating permit requirements.
- SOP development and revision related to process and equipment changes.
Education- Bachelors Degree in Engineering
- 0-4 years of experience
- Familiarity with cGMP regulations (21 CFR Parts 210/211 preferred).
- Strong technical writing skills pertaining to validation protocols and reports.
- Basic understanding of equipment qualification (IQ/OQ/PQ).
- Ability to analyze process data using statistical methods.
- Strong organizational and communication skills.
- Working knowledge of AutoCAD software for equipment layout, mechanical design modifications, or facility integration planning.
- RCRA training
EOE/ADA
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