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Validation Engineer

Non-Headquarters

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.

Validation Engineer

Location: California, United States

Job Description:

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 equipment, facilities, and processes 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) is a plus.

Join Us:

Salary Range: $90000 - $110000 / year salary range is an estimate of pay for project-based employment. 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.

Valspec offers a standout culture, fantastic work environment, and has very competitive benefits to include premium medical, 401K match, profit sharing, tuition reimbursement, 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 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.

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