Process Engineer Consultant

• →Support commissioning, startup, and qualification activities for upstream and/or downstream manufacturing equipment.
• →Review and approve Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) documentation.
• →Draft, coordinate, and support Project Change Controls (PCCs) and Change Management Requests (CMRs).
• →Provide field execution support during startup, Set-to-Work (STW), commissioning, and qualification activities.
• →Support equipment procurement, implementation, and lifecycle management activities.
• →Assist with CMMS updates, preventive maintenance creation, and equipment record management.
• →Review, update, and approve Standard Operating Procedures (SOPs) and related GMP documentation.
• →Provide engineering support for capital projects involving modifications to existing systems and implementation of new equipment or processes.
• →Collaborate with Manufacturing, Engineering, Validation, Automation, Quality, and Maintenance teams to ensure successful project execution.
• →Support troubleshooting, deviation resolution, and operational readiness activities during project execution.
• →Ensure all project activities are performed in accordance with cGMP requirements, site procedures, and applicable regulatory standards.

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Bioengineering, or a related technical discipline.
• 3+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Experience supporting commissioning, qualification, validation, startup, and operational readiness activities.
• Familiarity with change management systems, deviation management, and GMP documentation practices.
• Strong understanding of manufacturing processes, process equipment, utilities, and facility operations.
• Excellent communication and collaboration skills with cross-functional teams.
• Ability to thrive in a fast-paced environment while supporting multiple priorities simultaneously.

• Start Date: ASAP
• Project Duration: Initial 6-month engagement with expected extensions up to 12 months or longer
• Experience Level: 3+ years
• Work Schedule: Full-time, onsite
• Industry: Pharmaceutical / Biotechnology Manufacturing

Success in this role requires more than technical expertise. We are seeking an individual who is:

• Easy-going and adaptable
• Able to remain calm under pressure
• Comfortable managing multiple priorities simultaneously
• Team-oriented with a strong work ethic
• Proactive and solution-focused
• Capable of building strong working relationships across departments
• Willing to take ownership and drive tasks to completion

This is an excellent opportunity to support critical manufacturing and capital projects within a highly regulated life sciences environment while working alongside industry-leading engineering and operational teams.