Process Engineer Consultant

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals. Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies. Process Engineer Consultant Valspec is a leading engineering and validation consulting firm serving the pharmaceutical, biotechnology, and life sciences industries. We provide expertise in process engineering, commissioning, qualification, validation, automation, and digital transformation projects. Our consultants work directly with clients to support manufacturing operations, capital projects, and regulatory compliance initiatives. Responsibilities Include (But Are Not Limited To): 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. Preferred Qualifications 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. Additional Details 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 What We're Looking For 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 o…