Engineer III, Validation & Operational Excellence

Position Summary:

Theragent is seeking a highly motivated Engineer III, Validation & Operational Excellence to lead and support validation, business analysis, and operational excellence projects to bring up a CGMP facility for cell and gene therapy.

The incumbent in this role will be trained to oversee and support implementation and validation projects of moderate to high complexity (equipment, utilities, facilities, processes, computerized systems, temperature mapping, etc.) in areas such as requirements gathering, engineering studies, determining validation approach, documentation generation and review (specifications, protocols, risk-assessments, etc.), and execution alongside in-house and validation contractors. With support, this role 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.

In addition, this cross-functional role will be involved with Business Analysis and Operational Excellence efforts, focusing on gathering business and workflow requirements, facilitating discussions between business stakeholders and technical teams, proposing viable technical solutions and workflows, and identifying opportunities for optimizing business operations for enhancing efficiency while ensuring compliance. Alongside and with guidance from the team, this position will be part of establishing and maturing all aspects of the validation, business analysis, and operational excellence programs required to maintain and optimize 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, experience in lean methodologies, quick to learn new technologies, and flexible to accommodate shifting priorities in a fast-paced startup environment.

This is a temp-to-hire role that can be either part-time or full-time. There is potential for conversion to a permanent position based on performance and business needs.

Primary Responsibilities:

• Qualification and Validation
  1. Lead and support GMP validation projects of moderate to high complexity (equipment, instruments, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resources
  2. Lead the requirements gathering process and support the implementation, integration, and risk-based qualification of IT systems and software for CGMP use, requiring proficient knowledge of SDLC, data integrity, and system integrations
  3. As required, develop qualification and validation lifecycle documents (requirements, risk assessments, protocols, etc.), execute the associated studies, analyze the resulting data, and develop the final report
  4. Serve as Theragent Validation SME for validation project scopes, approaches, and rationales
  5. Develop Standard Operating Procedures to develop and mature the Theragent Validation program
  6. Support validation deviation investigations and determine assignable cause alongside Validation Lead and contractors
  7. Review validation lifecycle documentation, including requirements, specifications, protocols, and reports
  8. Act as validation signatory representative to approve validation documentation, accountable to Theragent management and regulatory agencies
  9. Support the Validation Team in any required activities to support the development, execution, or improvement of the Theragent Validation program
  10. Understand the application of Data Integrity per 21 CFR Part 11
  11. Experience and familiarity with the application of FDA, GLP, QSR, and CGMP regulations
• Business Analysis and Operational Excellence
  1. Champions the implementation of new technologies and systems to meet business needs
  2. Conduct interviews and workshops to gather business and workflow requirements, creating detailed specifications and process documentation
  3. Collaborate with IT and other departments to design viable solutions, develop test plans, and organize user acceptance testing (UAT)
  4. Drive and improve results by leveraging lean tools (value stream mapping, DMAIC methodology, etc.), consulting skills, and change management processes, taking responsibility for implementation of lean initiatives within organizational value streams.
  5. Define KPIs, metrics and continuous improvement goals within the organization to drive business objectives in development and manufacturing services
  6. Assess with management major opportunities for throughput improvement to optimize organizational and business efficiency

Reports to: Associate Director, Validation & Operational Excellence

FLSA Status: Exempt

Location: Arcadia, CA

Knowledge, Skills & Abilities:

• Strong knowledge of computer system validation (CSV) for software applications
• Equipment qualification experience in a CGMP environment (IQ, OQ, PQ). Experience in the qualification of cell therapy equipment is a plus
• Strong understanding of the validation lifecycle in GMP settings
• Knowledge of Computerized Systems SDLC and data integrity principles
• Knowledge of CGMP, GAMP, 21CFR part 11, GDP
• Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment
• Experience in lean methodologies 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 4-6 years of relevant Validation, Business Analysis, and/or Operational Excellence 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.
• Strong background in computer system validation (CSV) is required.
• Six Sigma certification is a plus.

Working Conditions:

• Primarily office environment but will be required to enter GMP laboratory or manufacturing areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Must be able to read, write, and converse in English
• 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.
• Ability to work safely and effectively when working alone or working with others.

Travel: Occasional. Less than 10%

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.