Senior Manager, Validation Services (R1557524-en-us)
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.
Reporting to the Associate Director, Validation Services. The Validation Manager will oversee all validation activities; coordinate with Production, Quality, Maintenance, and other personnel as needed to complete projects and process improvements. The staff member will help to plan, manage, and execute the start-up, commissioning, and validation of new equipment, help create validation master/project plans, for the following Equipment and Utilities System Qualifications, Requalification, In-Process Equipment, Smoke Studies, Temperature Mapping Validations, and Facilities/Utilities Qualifications.
- Manage Validation and provide direction for multiple projects
- Approve protocols, reports and investigation reports
- Author, review and revise SOPs
- Prepare and maintain Department Validation Master Plan
- Administer training of employees by conducting training, authoring and revising training materials, and ensuring completion of training documentation
- Author, approve change controls
- Ensure observe calibration program for validation equipment
- Ensure accuracy of data presented in protocols and reports
- Ensure data is recorded and reviewed using good documentation practices
- Provide technical expertise and guidance on validation policies and procedure and the implementation of those within the production and quality control departments
- Recruit contract resources as necessary to deliver the Validation Master Plan and manage temporary resources employed
- Maintaining and improving the validation system aligned with the current with international standards and regulatory agencies
- Maintain requalification and revalidation schedules
Specific knowledge, etc:
- Experience managing technical group and collaborating with multi-teams
- Direct experience or close familiarity with equipment/utility/facility qualifications and general validation practices
- A working understanding of Six Sigma standards
- Excellent project management, communication, and technical writing skills are required
- Have technical competency required to represent the department before our customers, regulatory agencies, and management
BS degree in Engineering, Chemistry, or the Biological Sciences relevant experience or with direct validation experience and biopharmaceutical/pharmaceutical experience required.
Physical Demands/Work Environment:
- Office-based position, which requires appropriate levels of personal protective equipment (PPE) if fieldwork is required.
- Frequent repeated motions such as keyboarding is required.
- Position is based indoors and you will primarily work with others, but also alone at times.
This position requires up to 5% of travel.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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