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Added 1 hour ago
Engineering Director
Bridgenext
UNAVAILABLE
We are seeking a highly experienced Engineering Director to be a Data Solutions Architect in our Global Data Practice and Engineering & Technology team. This role requires a hands-on…
Added 7 hours ago
Associate Product Marketing Manager, Data & Analytics Solutions
BD (Becton, Dickinson and Company)
Durham, NC
Reporting directly to the Associate Director, Upstream Marketing and working under the guidance of product leadership, this individual will contribute to the global product strategy and…
Added 8 hours ago
Associate Director, R&D - New Product Development
BD (Becton, Dickinson and Company)
San Diego, CA
The Associate Director of R&D will serve as a technical leader for new product development within the Infusion business.
Added 11 hours ago
India Data & AI Associate Director
nVent
Bangalore, IN
Lead the India Data & AI organization as its most senior leader, setting the tone for culture, performance expectations, and professional standards
Added 21 hours ago
CL
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Cooley LLP
NY · Washington, DC · CO
- $140,000 to $170,000 USD / year
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Added 23 hours ago
Associate Director, Customer Engagement Platforms & Data
Travere Therapeutics, Inc.
Darbydale, OH
…science and service for rare patients*.* Position Summary: The Associate Director, Customer Engagement Platforms & Data is the hands-on BTS product and platform leader responsible for…
Added 1 day ago
M
Senior Director, Talent Acquisition Strategy, Product & Experience Design
Marriott
Bethesda, MD
- $151,100 to $264,000 USD / year
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Associate Director Annual Giving and Volunteer Engagement
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Development Associate / Analyst
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Director of Psychiatric Clinical Operations
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EI
Director of People & Culture
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Remote, United States
- $175,000 to $205,000 USD / year
Exante360, Inc., is looking for a Director of People & Culture that wants to join us on our bold initiative of “improving lives through relationships, by connecting people to solutions.”
Added 1 day ago
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Sr Associate-Digital Product Management - Enterprise AI Platforms
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Sunrise, FL
- $89,250 to $150,250 USD / year
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Senior SIEM Engineer
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Added 1 day ago
Salesforce/Applications Support Engineer
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Software Sales Associate Director - FinCrime
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…Core, Finance, Industry and Enterprise, Song, Supply Chain and Engineering, and Talent, with advanced capabilities in AI and Data, Industry and Process, and Technology. We serve…
Added 1 day ago
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Principal Data Scientist
AbbVie
Irvine, CA
- $124,500 to $236,500 USD / year
The Principal Data Scientist is the senior technical and scientific leader for AbbVie's omnichannel engagement analytics, a data and analytics-driven engagement optimization program…
Added 1 day ago
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Principal Data Scientist
AbbVie
Mettawa, IL
- $124,500 to $236,500 USD / year
The Principal Data Scientist is the senior technical and scientific leader for AbbVie's omnichannel engagement analytics, a data and analytics-driven engagement optimization program…
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Director, Operations & End-to-End Value Stream Leader- Dispensing Platform
BD (Becton, Dickinson and Company)
San Diego, CA
As a key member of the Dispensing Integrated Supply Chain staff, the Director, Operations & End-to-End Value Stream Leader- Dispensing Platform will be responsible for driving the…
Added 1 day ago
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Counselor/Coordinator, Disabled Student Program and Services (DSPS) (Full-Time, Categorically Funded) Reedley College
State Center Community College District
Fresno, CA
- $71,054 to $108,773 USD / year
- Full-time
Under the administrative direction of the Director, Disabled Student Programs & Services (DSP&S), the Counselor/Coordinator will provide a complete range of counseling, accommodation, and…

ProBio

Associate Director, Quality - Validation

Pennington, NJ, United States

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Job details

Experience: BS/MS in life science or related field with 10+ years of experience in drug/biologics industry in GMP production environment in roles of validation/engineering.
Posting language: English
Posted: Oct 28, 2026

Original job description

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.

About the Job:

The position reports to the Sr. Director, Quality Assurance and is responsible for leading a team of validation personnel to perform commissioning, qualification, and validation (CQV) activities for GMP manufacturing facilities, utilities, equipment, computerized systems, and manufacturing processes. This position plays a key role in supporting multiple client programs across clinical and commercial manufacturing within a fast-paced CDMO environment.

This person will lead the ongoing commissioning and qualification of the GMP Gene Therapy Areas, GMP Plasmid Manufacturing Area, the Quality Control (QC) laboratories, Microbiology, Raw Material, Sample and Stability areas. This includes facilities, utilities, systems, equipment, computerized systems, and instrument qualification/validation activities.

This person will work cross-functionally with internal departments (Analytical Development, Manufacturing, IT, EHS, etc.) and external resources (Vendors, Consultants, Contract Laboratories, etc.), both domestically and internationally, to support manufacturing and laboratory related issues. They will be accountable for realization of the site validation master plan, and to develop and maintain the re-qualification and equipment lifecycle program using quality risk management principles. This person manages direct reports and has the ability to develop, grow, direct and motivate a team in a fast-paced environment. The incumbent will be required to strategize long-term, maintain & execute a validation quality plan, and drive continuous improvement.

Responsibilities:

Lead a team to execute commissioning, qualification, and validation (CQV) activities for facilities, utilities, process equipment, and manufacturing systems.
Lead a team to develop, review, and execute IQ, OQ, PQ protocols and validation reports.
Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities.
Support technology transfer and startup activities for new client manufacturing programs.
Prepare and lead a team responsible for validation documentation in accordance with cGMP, FDA, EU GMP, GAMP 5, and 21 CFR Part 11 requirements.
Support deviation investigations, CAPAs, change controls, and risk assessments related to validation activities.
Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external vendors.
Lead a team to participate in FAT, SAT, commissioning, equipment qualification, and facility expansion projects.
Maintain validation documentation and ensure data integrity throughout the validation lifecycle.
Support client audits, regulatory inspections, and internal quality audits.
Identify opportunities for continuous improvement of validation processes and engineering systems.
Support multiple client projects simultaneously while ensuring project timelines and quality requirements are achieved.

Qualifications:

BS/MS in life science or related field with 10+ years of experience in drug/biologics industry in GMP production environment in roles of validation/engineering.
Working experience in CQV for biotechnology/pharmaceutical facility is required.
Familiar with CSV in accordance to GAMP 5 and CFR Part 11.
Familiarity with process, cleaning, assay validation a plus.
Experience in authoring of validation protocols for utility and equipment required.
Familiar with GMP operational principles and practice.
Ability to work across functional groups for team collaboration.

Pay range is estimated between $130k - $170k based on skill set and experience.

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Benefits:

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

ProBio Inc. maintains a drug-free workplace.

Please note: ProBio Inc. will only contact candidates through verified application sources. Probio does not request personal information from candidates through individual email or any other platform.

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