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Senior Validation Engineer

Company: Randstad USA
Location: Arcadia
Posted on: November 27, 2022

Job Description:

job summary:
Make a splash at this fast-paced and rapidly growing biotech start up! This is a great opportunity for a curious learner to support the development and manufacturing of cell and gene immunotherapies for the treatment of cancer and rare diseases.

Position Summary:

We are seeking a highly motivated Senior Validation Engineer to lead and support validation projects to bring up a cGMP facility for cell and gene therapy. The incumbent in this role will be trained to oversee and support validation projects of medium to high complexity (equipment, utilities, facilities, processes, computerized systems, etc.) in areas such as determining validation approach, engineering studies, documentation generation and review (specifications, protocols, risk-assessments, etc.), and execution alongside in-house and validation contractors. With support, they will manage contractors and act as validation signatory representative to review and approve validation lifecycle documentation for GMP use, accountable to management and regulatory agencies.

Alongside and with guidance from the Validation Team, this position will be part of establishing and maturing all aspects of the validation program required to maintain the company's cGMP facility for cell and gene therapy. This is an exciting position with great professional development opportunities with a quickly growing company.

The ideal candidate has a strong understanding of the validation lifecycle and quality systems, creative in their problem solving, and flexible to accommodate shifting priorities in a fast-paced startup environment.

Hours: 8:30 AM - 5:00 PM

location: Arcadia, California
job type: Permanent
salary: $93,000 - 110,000 per year
work hours: 9 to 5
education: Bachelors

  • Lead and support GMP validation projects of medium to high complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resources
  • Oversee, supervise, and train junior engineers in cGMP validation best practices
  • As required, 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, approaches, and rationales
  • Develop Standard Operating Procedures to develop and mature the 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 to management and regulatory agencies
  • Support the Validation Team in any required activities to support the development, execution, or improvement of the Validation program
  • Understand the application of Data Integrity per 21 CFR Part 11
  • Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulationsAdaptable skills:

    • Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
    • Ability to effectively manage multiple tasks and activities simultaneously.
    • Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook.
    • Able to quickly understand and learn new technologies
    • Creative in problem-solving abilities, able to think outside the box to find solutions
    • Self-motivated and self-starter, able to work independently with minimal supervision
    • Must be proactive, results oriented, and have strong attention to detail
    • Strong written and verbal communication skills (including technical writing skills)
    • Strong team player, able to meet deadlines and changing priorities -
      • A minimum of 5+ years of relevant Validation experience (Pharmaceutical, Life Sciences industry cGMP environment)
      • A Bachelor's degree in a science-related field, preferably Life Sciences or Engineering. Advanced degree is a plus.
      • Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
      • Equipment qualification experience in a cGMP environment (IQ, OQ, PQ), and understanding of cGMP regulations, preferably with cell and gene therapy is a plus
      • Strong understanding of the validation lifecycle in GMP settings
      • Knowledge of cGMP, GAMP, 21CFR part 11, GDP
      • Experience in the qualification of cell therapy equipment is a plusWorking Conditions:

        • May be required to work in controlled or clean room environments
        • Must be able to read, write, and converse in English
        • Travel: Occasional. Less than 10%
        • Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
        • Ability to sit, stand, walk and move within workspace for extended periods
        • Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling
        • Primarily office environment but will be required to enter laboratory or GMP process areas donning
        • proper gowning / lab coats or PPE such as safety glasses and shoes -
          skills: FDA, GLP (Good Laboratory Practice), Data Validation Plan, GMP (Good Manufacturing Practice)

          Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

          At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

          Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

          Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

          We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

          For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information. job summary: Seeking a highly motivated Validation Engineer II to lead and support validation projects to bring up a cGMP facility for cell and gene therapy. The incumbent in this role will be trained to oversee and support validation projects of simple to medium complexity (equipment, utilities, facilities, processes, computerized systems, etc.) in areas such as determining validation approach, engineering studies, documentation generation and review (sp Under the direction of Director of the Strategic Project Management Office, the Senior Project Manager will be responsible for managing large and/or complex programs and projects throughout AltaMed, including the clinical sites with the aims of improving patient health outcomes and business results. The focus will be to design, plan, manage and implement the highest priority strategic business initiatives with significant financial, process, information sy job summary: WHAT IS THE OPPORTUNITY? Senior Business Analyst ensures that our mission-critical nCino CRM platform is optimally deployed, supported and adopted by the bank. nCino Senior Business Analyst will work with business users to gather and define business requirements; translate the requirements into user stories, process changes and work flows to solve business problems. Work with Salesforce Center of Excellence business and technical teams and We will keep you updated when we have similar job postings. select frequency I consent to the use of my information for the purpose of sending me job alerts.

Keywords: Randstad USA, Arcadia , Senior Validation Engineer, Engineering , Arcadia, California

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