Shire Validation Manager in Lexington, Massachusetts

Primary Role:

The position holder is responsible for oversight and management of EFU Validation teams for the Massachusetts Biologics Operations facilities in Lexington and Cambridge, Massachusetts, USA.The job duties related to the position include, but are not limited to, the following areas:

  • Leadership of the facility validation team.

  • Support validation related activities for the design, commissioning, qualification and continued validation maintenance of all equipment facilities and utilities, including identification of opportunities for improvement.

  • Oversee development and execution of validation protocols and other documentation for all equipment, facilities and utilities within the manufacturing facilities. Ensure proper review by all necessary functions; oversee the execution of validation studies, as well as data analysis and compilation of data and results into summary and final reports.

  • Review proposed changes to validated equipment, facilities and utilities via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status.

  • Maintain departmental expertise in validation and related activities. As a subject matter expert, represent these activities in discussions and communications with regulatory agencies.

  • Providing technical direction and guidance to Shire’s Validation specialists who work at the Site. Mentor and train Shire personnel in all aspects of EFU validation and other areas of expertise and develop employees and potential leaders within the Department.

  • Interface with other departments (e.g., Engineering, Facilities, Manufacturing, Regulatory Affairs, Quality Control and Quality Assurance) to ensure achievement of Shire objectives relating to validation and associated activities; including compliance with all applicable standards.

  • Assuring the ability to meet the Department goals in respect to Finance, Quality, Fulfillment, EHS

Contribute to alignment and harmonization of local validation practices with global.

Responsibilities:

40%:

Lead the facility validation team to ensure that production targets and budgets are met, that product and processes comply with cGMPs, product licenses and corporate policies, that quality documentation is complete and on time, and regulatory inspections are managed through satisfactory completion.

25%:

Strong focus on customer service, attention to detail, and continuous improvement activities to provide impeccable service to clients.

20%:

Develop organizational capabilities to ensure continued staff development.

15%:

In collaboration with the site lead, develop functional goals and drive and monitor performance against goals, objectives and KPIs.

Education and Experience Requirements:

Minimum Bachelors of Science in Engineering, Chemistry, Life Science, or other job related discipline with a minimum of 10 years relevant experience in the biotechnology and/or pharmaceutical industry.

• Experience in successful management of complex validation projects is required.

• proven track record of staff management, capable of developing people and teams with at least 3 years of management experience

• familiar with Quality Management Systems and GxP Regulations

• Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines.

• Operational Excellence experience to ensure value added and effective operations

Other Requirements:

Routine local travel between manufacturing sites is expected. Periodic domestic or international travel may be required for business meetings with corporate peers/collaborators, vendors/contractors, and to stay current with professional development opportunities. Incumbent will be required to carry a company mobile phone and be on call as required to support operations.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.