Director of Facility and Equipment Validation

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AGC Biologics are looking for a Director for Validation, with experience in international and national standards of equipment and facility validation/ qualification as required in a GMP aseptic manufacturing facility of biological API for phase I-III clinical trials and commercial manufacturing. AGC Biologics are growing and we are building a new mammalian production facility in CPH to be in use from Q3 2023. Beside the new builing also activities of new equipment and facility rebuilts are expanding.

About the Role

As Director of validation, Facility and Equipment (FE) you will have the daily management of an expanding team of highly qualified scientists and Subject Matter Experts. You will be overall responsible for the validation strategy for our Eqiuipment and Facility approved according to European Directive 2001/83/EC, 2017/1572 as well as FDA 21 CFR 210 and 211, including aspects of ASTM2500. Your area of responsibility will include current manufacturing facility and our expansion project.

At AGC, we use on a risk based validation approach and it will be your overall responsibility to keep our validation policies updated with current regulatory expectations as well business expetations.

We are actively involved in the constant development within our field and the continuous improvement of our quality system. We ensure that Manufacturing, Enginering, and QC are in compliance with standards for cGMP production, i.e. EU GMP, 21 CFR and ICH guidelines, and you will be a important collaborator on defining world wide policies.

You will cover strategic and tactical leadership for the Validation FE team responsible for procedures and policies for equipment and facility validation/ qualification and for validation of our expansion projects.

Validation FE, consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance and validation.

The team is responsible for Master Validations plans, execution of validation, contribution to customer regulatory files, risk assessments in regard to validation strategies, contribution to regulatory inspections and customer audites and evaluation of re-qualification requirements.

PRINCIPAL RESPONSIBILITIES:

  • Provide leadership and vision to drive a quality culture by developing a riskbased validation FE strategy to ensure business goals.
  • Department management ensuring a staff training program and a talent management program for the team
  • Budget responsible for the department.
  • Routinely present information to executive management related to site performance on the new bulding validation and deliveries to milestone plan for both building and customer projects.
  • Participate in CAPEX meeting to timely plan execution of validation activities.
  • Drive collaboration across site functions to ensure effective and compliant validation processes and engage in cross-functional planning to leverage resources to improve speed of resolution
  • Partner with community peers at the operational sites to share and adopt best practices across the network to drive continuous improvement.
  • Allign local procedures and policies with global policies. Partner with with global quality teams to set a “state of art” policy for facility and equipment validation.
  • Routinely participate in internal and external audits and inspections.
  • Contribute to Annual Product Review and BLA process for commercial projects

QUALIFICATIONS :

We look for director with analytical and problem-solving skills. Strong decision making skills and ‘can do’ attitude. Ability to work in a fast paced, matrix environment is essential. Capable of working to deadlines and prioritize multiple tasks. Flexibility to meet changing needs and priorities of the business. Strong ability to work independently.

You will recognize the following:

  • Technical expertise in regulatory requirements for a risk based approach to validation.
  • Skilled in strategic thinking, managing through systems, communication and negotiation
  • Actively develops and maintains strong professional relationships building trust and respect across the organization
  • Lead through influence, effectively build alignment and collaborate with multiple stakeholders
  • Assess performance roadblocks and develop appropriate solutions
  • Willing to have difficult conversations, meetings, and make decisions related to readiness of areas for inspection
  • Facilitate organizational change related to validation across multiple functions

EDUCATION/EXPERIENCE:

  • M.Sc. in chemistry or life sciences or equivalent experience
  • 10+ years of relevant experience in a pharmaceutical or FDA/GMP environment
  • Direct experience leading or supporting multiple functions in a pharmaceutical, biotech or a regulatory industry is requires
  • Experience in leading validation of large built projects for facilities as well as utilities and equipment.
  • Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated

Contact and application

For any further questions, your are more than welcome to contact Lise Marie Christensen at [email protected]. Please be aware that we take in consideration only the applications send via our career page and, not via email. We will process the applications as they arrive.

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.

Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


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Jobbet er oprettet på vores service den 11.2.2022, men kan have været deaktiveret og genaktiveret igen.

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