Validation Engineer bei Valpro
Valpro · Vereinigte Staaten Von Amerika · On-site
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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.
Validation Engineer
Location: Northwest of Los Angeles, California, United States
Summary:
We are seeking a talented Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring the quality and compliance of our manufacturing processes and systems. You will be responsible for designing, implementing, and executing validation protocols to ensure that equipment, facilities, and processes meet regulatory requirements and industry standards.
Key Responsibilities:
- Design and develop validation protocols for SCADA technology used in the manufacture of cell and gene therapy products.
- Execute validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV).
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs, to ensure alignment of validation activities with regulatory requirements and company standards.
- Perform risk assessments and impact analyses to identify potential validation gaps and develop mitigation strategies.
- Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs), in compliance with regulatory guidelines and internal procedures.
- Conduct validation testing and data analysis to ensure the reliability, repeatability, and robustness of manufacturing processes and systems.
- Investigate deviations, discrepancies, and non-conformances related to validation activities and implement corrective and preventive actions (CAPAs) as necessary.
- Stay current on industry trends, regulatory changes, and best practices in validation engineering.
Qualifications:
- Bachelor's degree in Engineering, Biology, Chemistry, or related field.
- Experience in validation engineering, preferably in the biopharmaceutical or pharmaceutical industry.
- Strong knowledge of validation principles, practices, and regulatory requirements, including FDA, EMA, and ICH guidelines.
- Experience with validation of equipment, utilities, facilities, and processes used in GMP manufacturing.
- Familiarity with risk assessment methodologies, statistical analysis, and validation documentation.
- Excellent analytical skills with attention to detail and accuracy.
- Strong communication and interpersonal skills, with the ability to collaborate effectively across functional teams.
- Ability to work independently and manage multiple projects simultaneously.
- Experience with computerized systems validation (CSV), specifically SCADA or PLC.
Join Us:
Salary Range: $80 - $90 per hour range is an estimate of pay for project-based employment (6 months+) for local candidates. This is onsite 5 days per week. Range varies based on knowledge and experience. Higher rates for short-term assignments and independent contractors. If you are a dedicated Validation Engineer with a passion for ensuring the quality and compliance of manufacturing processes in the biopharmaceutical industry, we want to hear from you! Join us on our mission to revolutionize medicine and transform lives. Apply now to be part of a dynamic team driving innovation in California and beyond.
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 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.
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