Process Engineer

Key Responsibilities

• Serve as SME and process owner for technology transfer and new product introduction (NPI).
• Conduct facility, equipment, process fit assessments, gap analysis, and risk assessments.
• Author, review, and approve cGMP documents, SOPs, batch records, protocols, and reports.
• Provide manufacturing floor support, troubleshooting, root cause analysis, and CAPA implementation.
• Analyze manufacturing data, identify trends, and drive process improvements.
• Lead process validation, PPQ, equipment qualification, and lifecycle management activities.
• Support new equipment, materials, and technology implementation.
• Ensure compliance with cGMP and regulatory requirements.
• Collaborate with Manufacturing, Process Development, Supply Chain, vendors, and clients.
• Monitor site KPIs and support employee training.

Position Requirements

• Bachelor’s or advanced degree in Science, Chemistry, Biology, or Chemical/Biological Engineering.
• Minimum 5 years of industry experience, including 3 years in cGMP biologics/cell therapy manufacturing or process development.
• Strong knowledge of bioprocessing principles and cGMP regulations (21 CFR Parts 11, 210, and 211).
• Experience in process validation, equipment qualification, and technology transfer.
• Familiarity with cell therapy processes, cleanroom facilities, and manufacturing equipment preferred.
• Experience with biopharmaceutical facility startup, validation, and licensure is a plus.
• Proficiency in MS Office and manufacturing data analysis tools.
• Strong communication, problem-solving, strategic thinking, and cross-functional collaboration skills.
• Ability to manage priorities in a dynamic manufacturing environment and work in Grade B gowning conditions.

With almost four decades of experience as a proven industry leader, Acro continues to be consistently recognized among the Best & Brightest Companies to Work for in the United States. As an international professional services firm with deep expertise in consulting and staff augmentation offering a variety of solutions including MSP, VMS, RPO, HRO (and more), Acro operates across North America, Europe, and Asia from over 30 locations. Acro’s client portfolio includes some of the most well-known names in business and provides services across all verticals including technology, aerospace, energy, automotive, government, and manufacturing. To learn more, please visit www.acrocorp.com.