Process Engineer Consultant Valspec - 4.6 Raleigh, NC Job Details Full-time 1 hour ago Benefits Health insurance Tuition reimbursement 401(k) matching Employee stock ownership plan Qualifications Bachelor's degree in mechanical engineering Practicing in a sourcing or procurement role Record keeping Project engineering Chemical Engineering Preventive maintenance Technical documentation Project change management Bioengineering Mechanical Engineering Mechanical system commissioning projects Production deviation management Equipment troubleshooting Employee relationship building Mid-level 3 years CMMS Change management Manufacturing standard operating procedures Manufacturing facility experience Bachelor's degree in engineering Production validation processes Maintenance records management Pharmaceutical company experience Compliance documentation Quality compliance management Regulatory/legal compliance standards in production Bachelor's degree in chemical engineering Collaboration with manufacturing teams Industrial equipment Full Job Description 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 operational teams. Why Join Valspec? At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including: Premium medical coverage 401(k) with company match Tuition reimbursement Unique performance incentives And more — all designed to support your growth, well-being, and future. Join a team where your contributions matter, your development is prioritized, and your success is shared. When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net. Any other domains are impersonations and should be ignored. Candidates must be legally eligible to work in the United States without company sponsorship. Also, we are not interested in working on a corp-to-corp basis with other companies at this time. Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.