Validation Engineer II
Company: Theragent, Inc.
Location: Arcadia
Posted on: August 3, 2022
Job Description:
Validation Engineer II 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 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 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 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 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 3-5 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. 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 , Validation Engineer II, Other , Arcadia, California
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