Manager, Quality Engineering
Bristol Myers Squibb
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Manager, Quality Engineering

Bristol Myers Squibb

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Details
Posted:
February 22, 2021
Location:
Devens, Massachusetts
Type:
Full Time - Experienced

Job Responsibilities

  • Provides document review and approval for facility, equipment, and utility commissioning and qualification, process validation, computer system and analytical validation documentation to ensure compliance with policies and procedures. 
  • 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.
  • Supports the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems.
  • Provides quality oversight for calibration and maintenance activities.
  • Identifies unresolved issues/decisions related to validation documents and escalates, as appropriate.
  • Demonstrates appropriate examples for compliance behaviors and attitudes.
  • Meets and exceeds all safety expectations and adheres to all BMS behaviors. 
  • Seeks opportunities for continuous improvement.
  • Assists in responding to inquiries from audits and inspections from world health authorities.
  • Provides Quality oversight on Technology Transfer initiatives.
  • Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.

Qualifications and Education Requirements

  • 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 5 years experience in an environment governed by cGMPs, including at least 3 years of related experience, (e.g., equipment qualification, computer system validation, analytical equipment / method validation, or process validation).  
  • Knowledge of cGMP and regulatory requirements for validation of equipment, computerized systems, and processes.
  • Proficiency in the use of computers and software applications including electronic change control systems
  • Demonstrated interpersonal, communication, and motivation skills.
  • Knowledge of applicable business systems including: SAP, LIMS, Maximo and Veeva Vault are desirable
  • Knowledge of manufacturing executions systems such as Syncade and distributive control systems such as DeltaV is desirable
  • Effective written and verbal communication skills

Internal Number: R1534910
About Bristol Myers Squibb
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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