Jobs in the United States

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Added 12 hours ago
A
Associate Process Engineer, Cell Therapy Process Development
AstraZeneca
Santa Monica, CA · Santa Monica
- $67,000 to $101,000 USD / year
We are seeking a highly motivated Associate Process Engineer to support late-stage cell therapy process development and characterization activities. In this role, you will play critical…
Added 12 hours ago
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Senior Associate Process Engineer (Contract)
ElevateBio
Waltham, MA
- $43 to $57 USD / hour
ElevateBio is looking for a Senior Associate Process Engineer within the Manufacturing Science and Technology (MSAT) organization. As a Senior Associate Process Engineer in MSAT, you will…
Added 12 hours ago
AP
Associate Process Engineer, Cell Therapy Process Development
AstraZeneca Pharmaceuticals LP Company
Santa Monica Colorado Avenue, CA
- $67,000 to $101,000 USD / year
We are seeking a highly motivated Associate Process Engineer to support late-stage cell therapy process development and characterization activities. In this role, you will play critical…
Added 13 hours ago
Senior Automation Engineer
Catalent Pharma Solutions LLC
Harmans, MD
The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
Added 12 days ago
Senior Manager, Data Engineer, Clinical Operations
Bristol Myers Squibb
Princeton, NJ
…optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to…
Added 12 days ago
Senior Manager, Quality Assurance Shop Floor
Bristol Myers Squibb
Devens, MA
…role in ensuring the highest quality standards in our cGMP Cell Therapy processes. The QASF organization is responsible for quality oversight of shop-floor activities at the Devens Cell…
Added 14 days ago
Assistant/Associate/Full Professor of Bioengineering: Synthetic Biology (2 positions)
UO HR Website
Eugene, OR
…engineered cells, microbial communities, biomaterials, and cell and gene therapy products; computational methods for genome engineering and synthetic genome design; design and analysis of…
Added 14 days ago
Associate Director, FP&A
BlueRock Therapeutics LP
United States
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines.…
Added 14 days ago
Associate Director, Translational Medicine and Nonclinical Development
BlueRock Therapeutics LP
United States
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company pioneering a new generation of cellular medicines.…
Added 14 days ago
Research Associate I, Process Development
BlueRock Therapeutics LP
United States
BlueRock Therapeutics is seeking a Research Associate I, Process Development in New York City, NYC. As a central development resource at the company, the Process Development team works…
Added 15 days ago
AT
Associate Director, Analytical Development / Quality Control
Azalea Therapeutics, Inc.
Berkeley, CA
- $170,000 to $210,000 USD / year
…new way to turn a person’s own T cells into a powerful cancer therapy directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing…
Added 15 days ago
AT
Senior Research Associate/Associate Scientist, Synthetic Immunology
Azalea Therapeutics, Inc.
Berkeley, CA
- $105,000 to $125,000 USD / year
…new way to turn a person’s own T cells into a powerful cancer therapy - directly inside the body. Instead of removing cells and manipulating them in a lab, we use precision genome editing…
Added 15 days ago
AT
Research Associate I/II (Molecular Biology)
Azalea Therapeutics, Inc.
Berkeley, CA
- $70,000 to $90,000 USD / year
Azalea Therapeutics is seeking a Research Associate I/II to join its Research & Development team. This hands-on laboratory role will support the advancement of AZA-2509 and Azalea’s…
Added 15 days ago
AT
Research Associate I/II (Cell-Based Assay Development)
Azalea Therapeutics, Inc.
Berkeley, CA
- $70,000 to $90,000 USD / year
Azalea Therapeutics is seeking a Research Associate I/II to join its Research & Development team. This hands-on laboratory role will support the advancement of AZA-2509 and Azalea’s…
Added 17 days ago
Engineer III, Validation & Operational Excellence
Theragent Inc
Arcadia, CA
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…
Added 17 days ago
Research Associate II/Sr Research Assoc Cell Process Development
Arcellx Inc
Rockville, MD
Key contributor to the development of phase-appropriate manufacturing processes for Arcellx cell therapy products. The candidate will be a highly motivated engineer/scientist with good…
Added 18 days ago
Maintenance Engineer
HUMACYTE GLOBAL INC
Durham, NC
…for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and…
Added 18 days ago
Associate Scientist II
Integrated Resources INC
Durham, NC
The Associate Scientist II/Engineer II will join a team of scientists responsible for the development of perfusion bioprocess used for the clinical and commercial manufacture of biologics…
Added 18 days ago
CTE Health Sciences Teacher
Edgecombe County Public Schools
Tarboro, NC
722 Health Science Education-Biotechnology July 1, 2025 Minimum Degree Level Bachelor's or Associate Related Degrees Biotechnology, Biomedical engineering, Biology-Related Degrees…
Added 18 days ago
Senior Manager, Quality Assurance Shop Floor
Devens
Devens, MA
…role in ensuring the highest quality standards in our cGMP Cell Therapy processes. The QASF organization is responsible for quality oversight of shop-floor activities at the Devens Cell…
Added 18 days ago
Packaging/Medical Device Quality Engineer
CSL Behring L.L.C.
Seqirus USA, MA
1. Serve as Medical Device and Packaging QA Associate on assigned combination product development projects. Work with project leaders and both internal and external team members to ensure…
Added 18 days ago
Associate Quality Engineer, Combination Products
CSL Behring L.L.C.
Seqirus USA, MA
As a part of the Quality for Combination Products and Medical Devices (CP/MD QA) department, the Associate Quality Engineer will support Quality activities in global teams involved in the…
Added 19 days ago
RU
MES Software Systems Engineer
RoslinCT US
Hopkinton
- $65,000 to $98,000 USD / year
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated,…
Added 20 days ago
Scientist 3/Engineer 3, MSAT
Fujifilm
Holly Springs, NC
Prior drug substance and manufacturing experience, including process development, validation, and transfer

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Theragent Inc

Engineer III, Validation & Operational Excellence

Arcadia, CA, United States

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Job details

Experience: A minimum of 4-6+ years of relevant Validation, Business Analysis, and/or Operational Excellence experience (Pharmaceutical, Life Sciences industry CGMP environment)
Posting language: English
Posted: Aug 19, 2024

Original job description

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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
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
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
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
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
Business Analysis and Operational Excellence
Champions the implementation of new technologies and systems to meet business needs
Conduct interviews and workshops to gather business and workflow requirements, creating detailed specifications and process documentation
Collaborate with IT and other departments to design viable solutions, develop test plans, and organize user acceptance testing (UAT)
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.
Define KPIs, metrics and continuous improvement goals within the organization to drive business objectives in development and manufacturing services
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.

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More about this job

Skills

Business analysis
Requirements gathering
Documentation
Good manufacturing practices
Workflow
Regulatory compliance
Good laboratory practices
Perform interviews
Change management
Process improvement
SAP IQ
Interpersonal skills
Multitasking
Organizational skills
Computer skills
Microsoft Office
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Problem solving
Work independently
Attention to detail
Communication skills
Technical writing
Meet deadlines
Heavy lifting

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