QA 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.

Automation QA Engineer

Location: Remote
Employment Type: Contract / Consulting (6-12+ months)
Start Date: ASAP

About the Role: We are seeking experienced Automation QA Engineers to support our clients in North Carolina. These roles will support automation quality assurance activities within a GMP-regulated pharmaceutical manufacturing environment, with a strong focus on commissioning, qualification, validation, and lifecycle documentation for automation systems. This is an excellent opportunity for candidates with pharmaceutical or biotech automation QA experience who are comfortable working cross-functionally with Validation, Engineering, Manufacturing, and Quality teams in support of large-scale capital and operational projects.

Key Responsibilities

Provide QA oversight and support for automation-related qualification and validation activities

Review and approve validation lifecycle documentation including:

IQ/OQ/PQ protocols and reports

Risk assessments

Traceability matrices

Change controls

Deviations and CAPAs

Support automation systems operating within GMP manufacturing environments

Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements

Partner with Automation, CQV, CSV, Manufacturing, and Quality teams to ensure compliant execution of project deliverables

Participate in document reviews, project meetings, and quality assessments

Support audit readiness and inspection preparedness activities

Assist with implementation and continuous improvement of validation and QA processes

Preferred Systems / Technologies

Experience with one or more of the following is highly preferred:

DeltaV

Rockwell / PLC systems

SCADA or HMI platforms

MES systems (Syncade experience is a plus)

Historian systems

Automated manufacturing equipment within pharma/biotech environments

 Qualifications

Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related field preferred

3+ years of experience in Automation QA, CSV, CQV, or Validation within the pharmaceutical, biotech, or regulated manufacturing industry

Strong understanding of GMP compliance and validation lifecycle principles

Experience reviewing and approving GMP documentation

Familiarity with data integrity and 21 CFR Part 11 requirements

Excellent communication and cross-functional collaboration skills

Ability to work independently in a remote environment

 
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.