What are the responsibilities and job description for the Process Engineer - Capital Projects position at Process, Automation & Commissioning Engineers, Inc.?
We are seeking an experienced Process Engineer to support capital projects in the pharmaceutical and life sciences industry. This individual will play a key role in the design, specification, installation, and optimization of process equipment and systems for biotech, pharmaceutical, and advanced therapy manufacturing facilities. The ideal candidate has strong technical expertise, a proactive approach, excellent communication skills, and the ability to collaborate effectively across multidisciplinary teams.
Key Responsibilities:
- Provide process engineering support for capital projects, including facility expansions, equipment installations, and process improvements.
- Develop and/or review process design documents, including PFDs, P&IDs, equipment specifications, material and energy balances, and mass flow diagrams.
- Support the selection, procurement, and integration of bioprocess and pharmaceutical equipment, ensuring compliance with cGMP and industry standards.
- Work with cross-functional teams—including engineering, operations, quality, automation, and validation—to ensure seamless project execution.
- Assist in the development and execution of commissioning, qualification, and validation (CQV) activities, including IQ/OQ/PQ protocols.
- Troubleshoot and optimize existing manufacturing processes, recommending improvements for efficiency, safety, and regulatory compliance.
- Ensure projects align with FDA, EMA, ISPE, and ASME BPE guidelines for biopharmaceutical processing.
- Participate in risk assessments, HAZOP reviews, and failure mode effect analysis (FMEA) to ensure process safety and reliability.
- Track and report project milestones, progress, and key performance indicators (KPIs) to stakeholders.
- Foster a collaborative and solutions-driven work environment, ensuring clear and effective communication with project teams.
Education & Experience:
- 5-10 years of experience in process engineering within the pharmaceutical, biotech, or life sciences industry.
- Strong understanding of cGMP regulations, process validation, and biopharmaceutical equipment design.
- Hands-on experience with bioreactors, chromatography skids, filtration systems, CIP/SIP systems, aseptic manufacturing, clean utilities, and single-use technologies.
- Proficiency in process modeling and engineering software (e.g., Aspen Plus, AutoCAD, Bluebeam, or similar).
- Strong problem-solving skills with the ability to analyze complex technical challenges and implement solutions proactively.
- Excellent written and verbal communication skills, with the ability to work effectively with both technical and non-technical stakeholders.
- Demonstrated ability to manage multiple priorities while maintaining attention to detail and project deadlines.
Why Join Us:
- Opportunity to work with a dynamic, high-performing team in the life sciences industry.
- Be part of impactful pharmaceutical and biotech projects that contribute to healthcare advancements.
- Competitive compensation and professional growth opportunities in a fast-paced environment.