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Associate Director, Site Technical Services

3 months ago

Hopewell, New Jersey, United States BeiGene Full time

_General Description:
_


The Associate Director Site Technical Services is responsible for the day-to-day activities of the Validation team, Metrology, CMMS and other technical services functions.

Supports site objectives, whilst adhering to regulatory compliance and achieving commercial success. Reviews, authors and works with CQV validation of start-up Green-Field Project. Works with Drug substance, Drug Product, QC, and Warehouse areas to support validation activities. Represent the validation team in change control meetings.

Thes role will act as a point of contact with different business areas, lead and handle validation projects, ensure the validation program meets corporate and regulatory expectations, maintain Validation master plans, lead contractors for execution of validation work, develop risk assessments, support audits and inspections, write and implement Equipment, Facility and Process Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and write deviations, root causes, and corrective actions.

This role also will lead metrology activities including developing, reviewing, and approving relevant procedures, ensuring compliance with regulations and expectations.

Works to ensure the efficient and effective day to day operations of the validation area. Ensures the Validation function supports operational needs and ensures regulatory compliance requirements are met.

Note:
This is an on-site role (5 days/week) based in Hopewell, NJ.

_Essential Functions of the job:
_

  • Develop and approve cGMP documents including, but not limited to: Validation Protocols and Reports, Commissioning Reports, Master Validation Plans, SOP's, Comparability Reports, Aseptic Process Simulation Protocols and Reports, Cleaning Validation, Process Validation (PPQ).
  • Lead validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, SAT, IQ, OQ, PQ) etc.
  • Experience in Metrology principals, CMMS functionality, and SOP authoring.
  • Ensure the Validation department meets or improves key performance indicators (KPIs). Works to ensure all validation projects are on time and on budget. Ensures adequate validation resources. May manage validation consultants on a large project basis, as needed.
  • Leading and Managing projects for the validation of equipment, processes, and products to meet all safety, quality, regulatory and operational requirements
  • Review and approval of equipment specification/design/procurement/installation and validation.
  • Project planning and execution including scheduling, task management, milestone planning and reporting
  • Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures
  • Lead or manage validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQ, OQ, PQ, etc.).
  • Employee will be required to work closely with both manufacturing, quality, and engineer associates.
  • Maintaining the validation sample management, assessing the requirements for data acquisition, and coordinating validation projects.
  • Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
  • Position flows based on project needs up to and including quality approvals.
  • Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

_Core Competencies, Knowledge, and Skill Requirements_

  • Bachelors degree (ideally:
pharmaceutical sciences, engineering, chemistry, or related discipline).

  • Minimum of 8 years' experience (or 6 years with advanced degree) in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
  • Minimum of 4 years' experience in management, with knowledge of cGMP and Data Integrity principles.
  • Minimum of 2 years' experience in metrology and CMMS management.
  • Strong knowledge of cGMP's.
  • Knowledgeable in cGMP risk assessments and processes for following well documented and thought through risk-based approaches.
  • Biotech and/or Sterile manufacturing and aseptic processing knowledge required.
  • Knowledgeable in Computerized System Validation (CSV),Cleaning Validation, Process Validation and Equipment/Utility Validation.
  • Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
  • Credible and confident communicator (written and verbal) at all levels.
  • Strategic thinker, highly customer focused. Strong analytical and problem-solving ability.
  • Hands-on approach, with a 'can do' attitude. Able to work under minimal supervisor.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative. Good personal leadership.
  • Highly Desirable:
Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP.

_Significant Contacts_

  • Site leaders, site engineering department, frequently interacts with all levels of BeiGene manufacturing employees.

Supervisory Responsibilities:

  • Will have direct reports and may manage contractors.
Leads the engineering validation, metrology and CMMS teams.

Computer Skills:

  • Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module

Other Qualifications:

  • N/A

Travel:

  • Must be willing to travel approximately 10%; requires a valid passport.
  • Ability to work on a computer for extended periods of time


All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.