Group Manager, Validation Services - New York, Syracuse

The announced job offer is made public by the firm: Bristol Myers Squibb and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of New York at the city Syracuse, in the country US - at this current ZipCode: 13235

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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.

Position Summary

Reporting to the Validation Senior Manager, the Group Manager will provide second level oversight of validation activities and collaborate with customers to complete projects. The Group Manager will be responsible for planning, managing, and executing enhanced commissioning and validation activities of new equipment, and assist in the creation of validation master/project plans for, but not limited to: Equipment and Utilities System Qualifications, Requalification, In-Process Equipment, Air Flow Visualization Studies, Temperature Mapping, and Facilities/Utilities Qualifications. The Validation Manager may lead and/or coach junior team members and contractors during daily qualification activities when required.

Duties/Responsibilities:

Manage Validation sub-group and provide direction for multiple projects

Review and approve protocols, reports and investigation reports

Author, review and revise SOPs

Investigate process and quality problems and implement corrective actions

Identify and define project and process improvement opportunities and support process improvement projects

Develop project plans and timelines

Assist in the preparation and maintenance of the Validation Master Plan

Administer training of employees by conducting training, authoring and revising training materials, and ensuring completion of training documentation

Author, review and approve change controls

Ensure adherence to calibration program for validation equipment

Ensure accuracy of data presented in protocols and reports

Ensure data is recorded / 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 functional areas

Support Validation Services activities by writing and revising SOPs, training materials and change requests.

As a Validation Subject Mater Expert (SME) participate in both regulatory and internal inspections and ensures the timely correction of any outstanding items as a result of inspections.

Recruit contract resources as necessary to deliver the Validation Master Plan and manage temporary resources

Assist in maintaining and continually improving the validation program aligned with current international standards and regulatory agencies.

Maintain requalification and revalidation schedules

Qualifications, Specific Knowledge, Skills, Abilities, etc:

Experience managing technical group and collaborating with multi-functional teams.

Direct experience or close familiarity with equipment/utility/facility qualifications and general validation practices is desired.

A working understanding of Six Sigma principles is a plus.

Excellent project management, communication, and technical writing skills are required.

Possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.

Education/Experience/ Licenses/Certifications:

BS degree in Engineering, Chemistry, or the Biological Sciences relevant experience or with direct validation experience and biopharmaceutical/pharmaceutical experience required.

Physical Demands: This position is a primarily an office-based position, however, requires routine entry into laboratories to access instrumentation which requires appropriate levels of personal protective equipment (PPE). Frequent repeated motions such as lifting, bending, twisting, squatting, walking, and reaching is required. This role also requires occasional unassisted lifting (not to exceed 50 lbs). Office-based work requires sitting. Repetitive use of arms/hands/wrists, especially when working with a computer.

Work Environment: This position is based indoors in an office environment or laboratory setting, and will be primarily working with others, however, will also work independently and alone at times. Walking within and between buildings is required to enter laboratories and collaborate with others.

Travel: This position requires up to 5% of travel.

Supervisory Responsibilities: This position will supervise a team of validation engineers, scientists and in some cases contract technicians in the development, execution and summary report writing of validation protocols, test scripts, master plans, risk assessments etc. The Department will consist of both full time and contract resources. Number will vary based on number of projects in progress.

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 to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.