Senior Specialist, CTO MSAT Process Validation Engineer II

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.

PURPOSE AND SCOPE OF POSITION:

The Senior Specialist, Process Validation Engineer II is responsible for supporting the production of personalized cell therapy products for global clinical trials and commercial supply in the CTO Summit, NJ manufacturing site. The Senior Specialist develops and supports qualification and validation activities in a leading role (e.g. protocols, reports, site procedures and batch records, and agency filing content) satisfying internal and external regulatory expectations. The Senior Specialist will collaborate with Global MSAT as well as Product and Development, Manufacturing Operations (MO), Supply Chain (SC), Quality Control (QC) and Quality Assurance (QA) departments while providing technical support for the resolution of validation related project deliverables, evaluation and implementation of process changes and continuous process improvement support to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Expert knowledge of good manufacturing practices (GMP) and quality systems concepts.
• Familiarity with 21 CFR Part 11, cell therapy/ biopharmaceutical industry guidelines and/or health authority (HA) regulations and associated compliance documentation (e.g. FDA, EMA, Health Canada, IGJ, etc).
• Deep knowledge of manufacturing facility and clean room designs, cell therapy processes, equipment, automation, and validation activities.
• Hands-on experience with single-use technologies, closed systems, and cell therapy technologies.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities and cell therapy products.
• Sound scientific understanding of process validation principles and design.
• Experience with Change Controls, CAPAs, Deviations, standard operating procedures (SOPs), protocols and reports.
• Effectively communicates with internal and external cross-functional teams and represents department in collaborations to drive successful completion of projects within defined timelines across the cell therapy division and network.
• Must have strong authorship skills and be able to critically review protocols, investigations, deviations, reports, interpret results, and generate technical conclusions consistent with fundamental scientific knowledge, GMP and Good Documentation Practices (GDocP).
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, and analytical thinking.
• Ability to work independently with minimal direction to completes tasks, ability to obtain resources and information from established internal contacts; consults with supervisor for decisions outside established processes; authority to make daily decisions in support of team goals.
• Ability to prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Possesses strong leadership skills in a multi-project industry setting.

Education and Experience:

• Bachelor’s Degree required (science or engineering is preferred), Advanced Degree is a plus.
• 3 or more years of manufacturing support or related experience in the biopharmaceutical industry.
• 1 or more years of experience leading or executing process validation activities.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Support CAR-T manufacturing site Process Validation activities including, but not limited to, Aseptic Process Simulations/ Validations (APS/APV), Process Performance Qualifications (PPQ), Dynamic Airflow Visualization Studies, Container Closure Integrity Testing (CCIT), Continued Process Verification (CPV) programs and revalidation strategies to meet GMP deadlines, to ensure that the programs are compliant with regulatory agencies requirements.
• Execute all responsibilities to meet cGMP and 21 CFR Part11 data integrity requirements and ensure validation activities are maintained in a state of control and compliance.
• Contributes to development of process validation strategies, protocols, SOPs, and batch records for Cell Therapy manufacturing processes as well as data analysis and compilation of results.
• Ensure process validation standards, site validation master plans, process qualification strategies and CPV strategies are implemented consistently and support execution and closure of validation activities.
• Collaborate with internal and external cross-functional teams for validation executions, tech transfers, and new product launches to ensure that knowledge is transferred, control strategies are appropriate, and risks are analyzed to ensure that commercial processes are validation ready.
• Support process validation lifecycle activities by ensuring a state of control is maintained through CPV programs.
• Coordinate and collaborate with other departments (e.g., Process Engineering (PE), Facilities, Manufacturing Operations (MO), Quality Control (QC), Quality Assurance (QA), Supply Chain (SC) and Regulatory) to ensure achievement of objectives relating to process validation executions and associated activities, including compliance with all applicable standards.
• Leads APS/APV, PPQ and validation projects by providing technical oversight, coordinate preparation, training execution and oversight, and report closures throughout the product life cycle.
• Author, review and approve process validation protocols and reports, data retrieval, compilation, and verification from a variety of 21CFR Part 11 compliant electronic systems.
• Provide technical input, lead validation related deviations and investigations, perform root cause analysis and implement CAPAs, ensuring compliance with validated state of the manufacturing process.
• Supports and assesses site validation impacts to change initiatives and the implementation of process improvement initiatives via CAPAs and Change Controls to identify requirements necessary to maintain validated status.
• Author and support validation risk assessments for existing and new/changed processes.
• Must be able to work in controlled environments requiring clean room gowning in ISO 5, ISO 7, and ISO 8 areas.
• Is recognized Subject Matter Expert (SME) within the group.
• Support process validation deliverables for Health Authority (HA) regulatory submissions and inspections, maintaining permanent inspection readiness for process validation.
• Support stakeholders in accomplishing productivity goals with internal and external cross-functional teams.

Leadership Attributes:

• Create an environment of teamwork, open communication, and a sense of urgency
• Support the change agent in promoting flexibility, creativity, and accountability
• Support organizational strategic goals and objectives that are linked to the overall company strategy
• Build trust and effective relationships with peers and stakeholders
• Deliver business results through timely and quality decision making and advice
• Foster a culture of compliance and strong environmental, health, and safety performance
• Promote a mindset of continuous improvement, problem solving, and prevention

WORKING CONDITIONS (US Only):

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

• Work is performed 25% of the time in a manufacturing and/or laboratory setting, requiring clean room gowning in ISO 5, ISO 7, and ISO 8 areas.
• Flexibility to work extended hours (>8 hours/day), weekend and/or holidays when required to meet deadlines.

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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.

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