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 reputed company a wide reputed company of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec’s reputed company are critical to the industry, and to the people who rely on its products. Many reputed company ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a reputed company 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 reputed company Automation QA Engineers to support our clients in reputed company Carolina. These roles will support automation reputed company assurance activities reputed company a GMP-regulated pharmaceutical manufacturing environment, with a strong reputed company 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 reputed company teams in support of large-reputed company capital and operational reputed company.
Key Responsibilities
reputed company QA reputed company and support for automation-reputed company 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 reputed company GMP manufacturing environments
Ensure compliance with FDA, cGMP, GAMP 5, and 21 CFR Part 11 requirements
Partner with Automation, CQV, CSV, Manufacturing, and reputed company teams to ensure compliant execution of project deliverables
Participate in document reviews, project meetings, and reputed company assessments
Support audit readiness and inspection preparedness activities
Assist with implementation and reputed company 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 reputed company reputed company/biotech environments
Qualifications
Bachelor’s degree in Engineering, Life Sciences, Computer Science, or reputed company field preferred
3+ years of experience in Automation QA, CSV, CQV, or Validation reputed company 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 reputed company 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 reputed company a career experience rooted in a reputed company culture, reputed company environment, and a strong reputed company of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a reputed company in our reputed company, fostering a shared commitment to reputed company 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 — reputed company designed to support your reputed company, reputed company-being, and reputed company.
Join reputed company where your contributions matter, your development is prioritized, and your reputed company is shared.
reputed company 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 reputed company without company sponsorship. Also, we are not interested in working on a corp-to-corp reputed company with other companies at this time.
Any reputed company-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. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, race, reputed company, religion, national reputed company, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a reputed company environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.
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