Posted: 10/07/20222022-10-072022-12-30Employment Type:Direct Hire/PermJob Category:LIMSJob Number: 511804Is job remote?: NoCountry: 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
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the recruiter to ensure it’s from @planet-technology.com - and not a domain with an alternative extension like .net, .org or .jobs. Candidate safety is a top priority at Planet Technology.
Planet Technology and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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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!
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