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Quality Engineering Process Validation, Cell Therapy
Posted on 7/12/2022
Devens, MA, USA
Experience Level
Desired Skills
  • Knowledge of science generally attained through studies resulting in a Bachelor's Degree in a scientific or engineering discipline or its equivalent
  • A minimum of 6 years experience in an environment governed by cGMPs, including at least 3 years of validation-related experience, (e.g., equipment qualification, computer system validation, analytical equipment / method validation, or process validation), or equivalent expertise
  • Knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes
  • Firm understanding of quality systems
  • Proficiency in the use of computers and software applications including electronic change control systems
  • Able to work independently with demonstrated interpersonal, communication, and motivation skills
  • Must be action-oriented, customer-focused, and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking
  • Knowledge of applicable business systems including: SAP, LIMS, Maximo, DeltaV, Syncade, and Veeva Vault is desirable
  • Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable
  • Effective written and verbal communication skills
  • Supports the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems
  • Leads the local change review board, as necessary
  • Site Representative for the global change Review board
  • Provides guidance and change expertise to local change owners
  • Responsible for change control metrics, system health, and continuous improvements
  • Provides quality oversight to the following:
  • Process Validation Master Plans, risk assessments and strategies
  • Process performance qualification (PPQ) protocols/deviations/reports
  • Tech Transfer, scale-up and supporting studies
  • Provides document review and approval for facility, equipment, and utility commissioning and qualification, process validation, computer system and analytical validation documentation from both technical and compliance perspectives
  • Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence
  • Reviews and approves protocol discrepancies associated with the qualification and startup of the Devens Cell Therapy Facility and participates in resulting investigations and correction / corrective action planning
  • Provides quality oversight for calibration and maintenance activities
  • Identifies unresolved issues/decisions related to validation documents and coordinates resolution with other departments
  • Demonstrates appropriate examples for compliance behaviors and attitudes, thereby shaping the culture
  • Meets and exceeds all safety expectations and adheres to all BMS behaviors
  • Provides guidance and mentorship to less experienced staff and onboards consulting staff, as necessary
  • Identifies, advocates for, and drives opportunities for continuous improvement
  • Responds to inquiries from audits and inspections from world health authorities
  • Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications
Bristol-Myers Squibb

10,001+ employees

Biopharmaceutical development company
Company mission
Bristol-Myers Squibb engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of pharmaceuticals.