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 www.agcbio.com.
The Validation Engineer 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 Engineer 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.
KNOWLEDGE, SKILLS & ABILITIES:
- 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