Senior Manager, Validation - Arizona, Phoenix

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 Arizona at the city Phoenix, in the country US - at this current ZipCode: 85003

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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.

The Manager, Validation is responsible for planning, managing, and coordinating Validation activities for Production Equipment, Utilities and Laboratory Equipment through the complete validation life cycle. Serves as a Subject Matter Expert in validation and provides expert technical recommendations / guidance. Leads large scale projects, prepares and leads project schedules/project teams, executes complex validation studies, and performs associated data analysis

Required Competencies: Knowledge, Skills, and Abilities

• Advanced understanding of Validation concepts and requirements
• Advanced written and verbal communication skills
• Advanced knowledge and interpretation of cGMP
• Advanced critical reasoning and decision making skills
• Ability to deal appropriately with regulatory agencies
• Detailed knowledge of Validation industry and regulatory requirements, defend validation programs, processes, and protocols in internal and external audit
• Intermediate project management skills
• Ability to work independently, and lead and participate in a team
• Ability to develop others, delegate and motivate.
• Ability to interpret / write general business documents.
• Intermediate knowledge of Microsoft Word, Outlook, and Excel, Project, and Visio
• Advanced knowledge and interpretation of cGMP, intermediate knowledge of Validation industry and regulatory requirements
• Requires presentation development and delivery skills.

Duties and Responsibilities
Leads team in Validation document generation, management, and execution activities.

• Coordinate department validation activities within the production schedule and provide back up in the Sr. Manager's absence.
• Interface with engineering, validation, and end user groups as a subject matter expert to provide technical guidance with validation including but not limited to production and laboratory equipment, facilities, and critical utilities.
• Design the qualification approach, provide the scientific rationale and acceptance criteria, generate and approve validation protocols.
• Conduct, and assist others, in industry and regulatory research including research into industry standards/FDA guidelines for validation equipment / processes and make determinations regarding acceptance criteria and testing.
• Lead projects, prepare project schedules and execute validation studies, perform complex data analysis, and write protocol summaries, reports, and technical reports.
• Operate instrumentation; perform protocol execution and validation activities, including collection of samples associated with qualification.
• In coordination with Production and Validation management, schedule equipment times, prepare test equipment and assure that testing is completed according to approved validation protocols.
• Conduct training for internal customers on protocols associated with newly validated equipment, systems, processes and specifications when transferring them to responsible operating group.
• Lead validation exception investigations associated with qualification activities.
• Perform Validation exception investigations associated with qualification activities

Own and execute complex projects, programs, procedures, investigations, and activities.

• Design, implement, and maintain validation programs related to equipment, utility, and facility validation, including but not limited to steam sterilization and depyrogenation, HEPA testing and management, critical utility systems and requirements, and equipment vendor selection.
• Manage projects in the work group and lead specific project teams (and multiple projects), coordinate the execution of validation projects, prepare project schedules and provide presentations to senior management / stakeholders on project status. Manage timelines, resources, and communications specific to individual tasks.
• Own department programs and SOPs, and generate revisions as required based on current industry standards and regulatory requirements.
• Execute CAPA plans, risk programs and assessments, investigations, and root cause analysis.
• Intermediate understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
• Interact and collaborate with departments (on and offsite) as well as vendors, consultants and other external service providers.
• Write and process change controls, assess impact to validated equipment, utilities, facilities, and processes.
• Coordinate and lead other Validation Scientists in the work group and provide technical expertise related to validation approaches and rationales.
• Train and mentor less experienced department personnel.

Performs general administrative and organizational activities.

• Conducts periodic safety inspections of Validation labs and office areas.
• Completes regulatory, site, and department training requirements on a timely basis.

Performs other tasks as assigned

Education and Experience

• Bachelor's degree preferred, preferably in Science or Engineering.
• Advanced degree preferred.
• 7 years' relevant work experience, preferably in a pharmaceutical or related manufacturing environment.
• An equivalent combination of education, experience and training may substitute.

Working Conditions

• The incumbent will be required to sit at a desk and type/view a monitor for extended periods of time.
• The incumbent will be required to push, pull, reach, balance, and/or lift greater than 25 lbs.
• The incumbent may be required to gown to Grade A, B, C and D requirements. This requires the ability to bend and move in order to gown aseptically.
• The incumbent must have the ability to pass an initial full physical exam, potentially including a respiratory certification with annual monitoring.
• The incumbent may be required to distinguish colors and possess correctable vision to 20/20. Annual eye exam may be required.
• The incumbent must be able to be trained to fall protection, and work in elevated environments as required.

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.

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