Sr Validation Engineer – Shire – Lexington, MA, USA
This position will be responsible for the validation activities for the design, startup, validation and ongoing operations of the existing Shire Massachusetts (Lexington site) Cell Banking and Warehouse operations, and GMP manufacturing validation support. Primary responsibilities include successful execution of the commissioning and validation program for the Cell Bank area GMP equipment, systems, and utilities, Environmental Chambers validation (warehouses, cold rooms, refrigerators, freezers, transport vehicles, and storage chambers), lab equipment, cold chain validation, and validation maintenance.
Technical duties include setting validation strategy, adhering to domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies, and participating in regulatory inspections.
Leadership duties include developing strategy, leading change and motivating others.
The scope of responsibility encompasses the product life cycle for existing commercial pharmaceutical and biopharmaceutical products as well as supporting technical transfer activities for emerging products and platforms.
Periodic travel may be required for business meetings with vendors/contractors and to stay current with professional development. Routine local travel to Shire HGT operational sites may be required.
Responsibilities:
30-80%: Write, execute, summarize, and lead validation activities in the
following areas:
• Facilities
• Equipment
• Utilities
• Shipping I Cold Chain
• Environmental Chambers
• Computer Systems / Plant Automation
• Validation Maintenance
• Validation document control and archival program
Develop and assess the following Quality System elements for
Validation:
• Quality Risk Management program
• CAPAs
• Change Controls
• Deviations
Participate and contribute in the design and development of GMP manufacturing equipment validation and controlled temperature unit validation strategy.
• Provide technical input to strategy / philosophy and assessment of engineering changes
• Represent validation during activities and lead validation efforts and manage projects as required.
• Lead technical projects as they pertain to GMP manufacturing equipment and controlled temperature units.
• Represent validation during audits / inspections (including front-facing) for validation technical expertise
Lead and manage complex validation and technical projects.
10-20%: Participate and lead partner audits and regulatory agency inspections for Validation.
Author and review responses to inspection observations and agency questions.
Author and review sections of regulatory filings and annual product quality reviews.
On-Going: Identify opportunities for continuous improvements, deploy best practices, and proactively update validation programs to reflect current regulations and trends.
Education & Experience Requirements:
Minimum requirements include a Bachelor’s degree in a technical discipline, preferably engineering or biological sciences, and a minimum of 5 years pharmaceutical and/or biopharmaceutical industry experience. An advanced degree or additional industry certification is a plus.
Other Job Requirements:
Interaction with Regulatory Agencies, Consultants/Contractors, and third party vendors & business partners.
