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 (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 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: Temporary
salary: $50 - 55 per hour
work hours: 9 to 5
- Lead and support GMP validation projects of simple to medium complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resources
- 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 regulations
- A minimum of 3-5 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.
- 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 multitasking 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
- 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
- Ability to work safely and effectively when working alone or working with others
skills: FDA, GLP (Good Laboratory Practice), Biomedical Engineering, GMP (Good Manufacturing Practice), Process Engineering
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 HRsupport@randstadusa.com.
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.