AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit


The Validation Specialist will support the Engineering, Facility/Labs, and Automation Manufacturing Support teams (metrology/calibration and maintenance) who are responsible for scale-up and manufacturing of cGMP protein-based therapeutics including cell and gene therapies.  Responsibilities include but not limited to cross-functional investigations and closure of quality events including Deviation, CAPA, and Change Control associated with facilities, utilities and equipment. Review and approval of validation documents and strategies.  The Validation Specialist also supports customer project and QA Validation teams and evaluation of risk assessments in order to maintain continuous improvement at AGC Biologics.


  • Designs, develops and leads Equipment and Facility Validation initiatives
  • Ensures that the Validation Master Plan remains current
  • Prepares/executes IQ/OQ/PQ protocols for equipment, instrument, facility and utilities (HVAC, Building Automation System, Compressed Air, Nitrogen system, and Environmental Monitoring) as well as related software to ensure compliance and adherence to cGMP and AGC Biologics validation standards
  • Identifies and resolves non-conformances/deviations encountered during IQ/OQ/PQ execution and work with Management to implement mitigation solution
  • Helps generate qualification report and helps summarize the results which will be reviewed by the Management
  • Performs re-qualification of equipment, facility and utilities as per change control requirements
  • Initiates a Problem Report/Record (change control, CAPA etc.) in a TrackWise system.
  • Develop and manage documentation for engineering studies (“ES”). Execute ES activities.
  • Develop and manage documentation for commissioning tests (“CT”). Execute CT activities as required
  • Develop and maintain the validation traceability matrix (“VTM”)
  • Provide data entry and statistical analysis of data collected during validation activities
  • Develop documentation for GMP criticality assessment and coordinate activities
  • Interprets validation/user requirements, provides validation strategy in conjunction with QA and operations organizations, develops and drafts validation protocols [i.e. Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification (DQ/IQ/OQ/PQ),] executes validations and documents validation results in final reports
  • Ensures that validations are documented using Good Documentation Practices and in compliance with Biologics and Regulatory Agencies, ISO Standards, and AGC Biologics Policies and Procedures
  • Perform and document investigations related to validation activities and performs risk assessments of equipment and processes to support scope of validation
  • Identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance
  • Provide quality-related discipline expertise to AGC customers and project teams
  • Performs other duties as assigned by Management.


  • Understanding of Biologics Manufacturing, Laboratory testing, and QA oversight.
  • Knowledge of ISO and GMP/ICH standards for equipment, facilities, automation and utilities.
  • Ability to clearly communicate validation compliance strategy, principles of quality, and rationale through oral and written communication techniques.
  • Demonstrated knowledge of scientific principles and concepts as they relate to Operations, Facilities, and Engineering teams.
  • Knowledge of CAPA, change control and deviation programs and requirements.
  • Team player who is collaborative with positive attitude.
  • Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
  • Strong interpersonal, written/oral communication and problem solving skills.
  • Experience with regulatory inspections, internal/external audits.


  • BA or BS with at least 5 years QA-related validation experience or equivalent work experience or a Master degree in a scientific discipline with at least 2 years related experience; may include equivalent work experience in a cGMP manufacturing facility.
  • Experience with application of validation compliance and principles of quality which drive QA strategy and oversight.
  • Experience in facilitating change control, deviations/investigations, and closure. Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure.
  • Equivalent education and experience may substitute for stated requirements.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances


Apply for this Job

* Required

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in AGC Biologics ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.