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.

SUMMARY:

The Validation Engineer will support the Site QA Validation, Facility and Manufacturing Support teams 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 equipment cleaning, facilities, and utilities. Review and approval of cleaning validation documents and strategies.  The Cleaning Validation Specialist also supports customer project, and all function teams and evaluation of risk assessments in order to maintain continuous improvement at AGC Biologics.

KEY RESPONSIBILIES:

  • Create cleaning cycle development strategies for a variety of equipment including: clean-in-place systems, packaging equipment, parts washers, cleaning matrices, and production facilities.
  • Write validation protocols and reports in support of the site’s validation program
  • Investigate and troubleshoot problems which occur during cleaning process
  • Responsible for planning and execution of onsite cleaning validation programs compliant with FDA requirements.
  • Prepare and review completed and executed validation packages by compiling and analyzing validation data for submittal for review and approval
  • Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval
  • Develops and authors change controls for cleaning process or equipment changes
  • Write and execute IQ/OQ/PQ/ and cycle development protocols including development of final reports.
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures
  • Write validation plans and risk assessments related to specific projects and facilities
  • Facilitate the development of user requirement specifications and operational SOPs for equipment.
  • Perform risk assessment and gap analysis for site cleaning programs.
  • Perform cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
  • Leads continuous improvement activities related to cleaning and changeover optimization
  • Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing effectiveness studies.

KNOWLEDGE, SKILLS & ABILITIES:

  • Demonstrated understanding reviewing/writing technical documents, risk assessment reports, validation documents, Cleaning validation protocols and final reports
  • Hands-on experience supporting/executing IQ, OQ (IOQ) equipment qualification related to various cleaning processes and activities
  • Understanding of cGMP regulation and quality management systems for Biologics operations and practices
  • Strong communication and presentation skills, both oral and written with a demonstrated ability to present key quality/department/business indicators to both first-line staff and senior management
  • Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
  • Must have strong ability to organize and manage multiple tasks in a fast-paced environment.
  • Team player

EDUCATION/EXPERIENCE:

  • BA or BS with at least 10 years Cleaning Validation-related experience or equivalent work experience or a Master degree in a scientific discipline with at least 5 years related experience; may include an equivalent work experience in a cGMP manufacturing facility.
  • Experience with application of compliance and principles of cleaning 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

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