Bristol Myers Squibb Senior Specialist, Quality Engineering in Devens, Massachusetts
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.
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 4 years experience in an environment governed by cGMPs, including at least 2 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
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Company: Bristol Myers Squibb
Req Number: R1534910-en-us
Updated: 2021-01-21 03:05:03.958 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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