Lead Validation Engineer
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.
LEAD VALIDATION ENGINEER
(AUTOMATION, INFORMATION & OPERATIONS TECHNOLOGY SOLUTIONS)
We are looking for tech savvy professionals with a proven track record in the SDLC (system development life cycle) of automated computer systems within biopharmaceutical environments. Due to our unique approach in meeting the demands of our customers, we are pursuing both individuals that can join our team long term as well as SMEs (subject matter experts) that would like to join us on a consulting basis.
Overview
This role supports the execution of small projects or portions of larger projects. Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality/Regulatory audits. Develops and executes qualification protocols and final summary reports and may participate in commissioning activities.
Requirements
- 8+ years of Computer System Validation (CSV) experience with process control, SCADA and automation systems, MES and data integration systems (Emerson DeltaV, Syncade / Rockwell PLC, PlantPAx, PMX / Siemens S7, Opcenter Execution Pharma / and/or Honeywell Experion, OSI PI experience is highly preferred)
- Experience with the commissioning and qualification of automation and related systems within virtual and production cGMP environments.
- Direct experience developing validation protocols and execution of protocols.
- Experience creating validation master plans and performing risk assessments.
- Knowledge of current industry standards such as GAMP5 and ASTM E2500.
- Passionate about leading and mentoring others.
- Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
- Excellent client communication skills.
Valpro offers flexible career options that includes benefits such as paid time off, paid holidays, medical, 401K match, and other unique incentives.
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.
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