QA Consultant

QA Consultant Valpro - 4.5 Boston, MA Job Details 19 hours ago Benefits Paid holidays Paid time off 401(k) matching Qualifications Quality control corrective actions Computer science Industrial automation Document review (document control) GAMP Human-machine interface (HMI) systems Computer Science Pharmaceutical regulatory compliance Engineering Corrective and preventive actions (CAPA) Mid-level 3 years Programmable logic controllers Bachelor's degree in engineering Continuous improvement Pharmaceutical plant experience Supervisory control and data acquisition (SCADA) Industrial equipment Quality assurance within manufacturing Manufacturing Commissioning phase involvement Cross-functional collaboration Bachelor's degree in computer science Communication skills Cross-functional communication FDA regulations Engineering validation Full Job Description Valpro has several available opportunities supporting our world-class client sites or partner organizations. Whether you are an independent consultant or a potential employee looking for your next project, learn more about what we have to offer. View our open positions below.

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, c

GMP, 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 Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives. 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 Valpro. Valpro will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established. Valpro 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.