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Senior Validation Engineer

Company: Theragent, Inc.
Location: Arcadia
Posted on: November 23, 2022

Job Description:

What We Do Theragent is a privately-owned Contract Development and Manufacturing Organization (CDMO) focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. We are a small, biotech startup headquartered in Arcadia, CA. Our state-of-the-art facility provide high-quality, reliable, and value-added solutions to our clientele for challenging pre-clinical and clinical trial projects. Our innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes. Why Theragent? Take the next step in your career and join Theragent today to change patient lives through the products we help develop and manufacture. Here, you will contribute your talents in a purposeful way that impact the lives of patients around the world. You will develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Innovation, Transparency, Accountability, Integrity, Diversity, Humility to name a few are embedded in everything we do. No matter your role may be, Theragent strives to ensure all our teammates are empowered and given the necessary tools to lead us in our relentless pursuit to extending patient lives. Our Mission: To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients. Position Summary: Theragent is 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 Theragent 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 Theragent 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. Primary Responsibilities:

  • 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 Theragent Validation SME for validation project scopes, approaches, and rationales
  • Develop Standard Operating Procedures to develop and mature the Theragent 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 Theragent management and regulatory agencies
  • Support the Validation Team in any required activities to support the development, execution, or improvement of the Theragent 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 regulations Reports to: Principal Validation Engineer FLSA Status: Exempt Location: Arcadia, CA Knowledge, Skills & Abilities:
    • 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
    • Experience in the qualification of cell therapy equipment is a plus
    • Excellent interpersonal skills with experience dealing with a diverse workforce
    • 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
    • Understanding of cGMP regulations, preferably with cell and gene therapy is a plus Education & Professional Experience:
      • A minimum of 5+ years of relevant Validation experience (Pharmaceutical, Life Sciences industry cGMP environment)
      • Bachelor's degree in a science-related field, preferably Life Sciences or Engineering. Advanced degree is a plus. Working 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% Physical / Mental Demands:
          • 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 Environmental Conditions:
            • 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
            • Ability to work safely and effectively when working alone or working with others This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities and activities may change at any time with or without notice. Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment. Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.

Keywords: Theragent, Inc., Arcadia , Senior Validation Engineer, Engineering , Arcadia, California

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