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Sr. Validation Engineer

san marino, CA 91108

Posted: 10/07/2022 Employment Type: Direct Hire/Perm Job Category: LIMS Job Number: 511804 Is job remote?: No Country: United States

Job Description


Validation Engineer – (Full-time) - Hybrid - CA

A fast-growing dynamic organization in San Marino CA is looking for a Validation Engineer to join a team of 5 and build the validation program from the ground up. This is a hybrid role that offers stock options next year, TONS of autonomy, and exposure to cell and gene therapy processes. The ideal candidate will have strong experience within the validation lifecycle – spec, risk, protocol generation, protocol execution, deviation resolution, final report, and IQ, OQ, PQ experience. An ability to interact with multiple departments with clear, concise communication is important. This exciting position offers excellent professional development opportunity and potential to move into a management role.

Benefits:
  • Health, Dental, Vision, Free Life
  • 401k 3% match then 50% up to 5%
  • 3 floating holidays
  • 2 weeks’ vacation year one
  • 40 hours sick time
  • 80 hours sick leave for covid
  • Stock options available in 2023

Responsibilities:
  • Lead GMP complex validation projects (equipment, computerized systems, utilities, facilities, processes, temperature mapping)
  • Manage and train junior engineers in cGMP validation best practices
  • Develop qualification and validation protocols, execute the associated studies, analyze the resulting data, and develop the final report
  • Serve as Validation SME for validation project scopes
  • Develop Standard Operating Procedures to develop and grow the in-house Validation program
  • Support validation deviation investigations and determine assignable cause alongside Validation Lead and contractors
  • Review validation lifecycle documentation, including requirements, specifications, protocols, and reports
  • Act as validation signatory representative to approve validation documentation, accountable management, and regulatory agencies
  • Understand the application of Data Integrity per 21 CFR Part 11
  • Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulations

Qualifications:
  • Ideally 5+ years of Validation experience within a cGMP environment - Pharmaceutical, Life Sciences
  • Bachelor’s degree in a science-related field, such as Engineering or Life Sciences
  • Good understanding of the validation approach and be able to develop specifications and requirements
  • Have an ability to validate and assess the gap between clients’ specifications and consultants' validation work
  • Must have IQ/OQ/PQ experience - specifically in writing protocols, specifications, FSDs, FRDs, reviewing the documents
  • Cell and gene therapy equipment qualification experience a plus
  • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ)
  • Strong understanding of the validation lifecycle in GMP settings
  • Knowledge of cGMP, GAMP, 21CFR part 11, GDP
  • Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
  • Ability to effectively manage multiple tasks and activities simultaneously.
  • Good proficiency in Word, Excel, PowerPoint, and Outlook.
  • Self-motivated and self-starter, able to work independently with minimal supervision
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About san marino, CA

Ready to elevate your career in the picturesque city of San Marino, California? Nestled near the famous Huntington Library, Art Museum, and Botanical Gardens, this charming locale offers a blend of cultural richness and professional growth opportunities. Imagine strolling through the stunning Lacy Park on your lunch break or catching a show at the historic El Portal Theatre in nearby Hollywood. With its proximity to world-class dining options and iconic attractions like the Rose Bowl Stadium in Pasadena, San Marino provides a perfect backdrop for career advancement and a fulfilling lifestyle. Explore our job listings today and embark on a career journey in this enchanting region!