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.
Job Title: GMP Equipment Validation Engineer – CQV
Location: Indianapolis, IN
We are seeking a highly motivated and detail-oriented GMP Equipment Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities for a range of manufacturing and utility equipment at a client site. This role is ideal for someone who thrives in a dynamic environment, can work independently, and is confident interfacing directly with client teams.
Our CQV team collaborates closely with the client across multiple facets of controls and automation, ensuring seamless integration and compliance with regulatory standards. The ideal candidate will bring strong technical expertise, excellent communication skills, and a proactive approach to problem-solving. The ideal candidate has experience leading the equipment CQV efforts of a team that also includes computer system validation engineers and specialists.
Key Responsibilities:
Lead and execute CQV activities for GMP equipment including:
Develop and review validation documentation including URS, DQ, IQ, OQ, and PQ protocols and reports.
Perform risk assessments and impact analyses to support validation strategy.
Coordinate with client engineering, automation, and quality teams to ensure alignment on project goals and timelines.
Troubleshoot and resolve equipment and process issues during commissioning and qualification phases.
Maintain compliance with cGMP, FDA, and other applicable regulatory requirements.
Provide timely updates and communicate effectively with client stakeholders.
Qualifications:
This is an excellent opportunity for anyone who can be onsite in NEPA and lead equipment CQV efforts, along with another team that is performing computer system validation. We will need others to be staff validation engineers in the future as well, but this is for someone who can work independently and provide some leadership on the technical side. Apply if interested.
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:
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.
Valspec is the leading provider of computer system validation and system life cycle (SLC) services including the testing, commissioning and qualification of manufacturing automation and IT systems. Valspec was established with a mission to meet the wide spectrum of services that help our clients meet their goals. Our proven history in plant automation and engineering services has allowed us to branch out and be highly effective in meeting a variety of project and resource needs.
We look for passionate engineers like yourself who are looking to:
•Be an innovator
•Work with the best and brightest
•Build the career you want
•Work for a company you can be proud of
Many of the projects that we work on assure that life-changing drugs are available to those who need them. Other projects have a goal of streamlining production to meet demand at a lower cost so that the drug companies have the means to discover new life saving therapies.
