Job Details
Engineering
Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us.
The Senior Manager supports the successful qualification of laboratory, clinical and commercial manufacturing systems to support operations at a multi-product site (Biologics / Cell Therapy) through interaction with internal team members and peer‐level customers as well as external service providers.
The incumbent in this role supervises entry, junior, and experienced level professionals tasked with qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual oversees multiple projects and ongoing work activities of all levels of complexity to ensure on time and within budget completion. In addition to answering questions and resolving issues for staff, the incumbent spends a small portion of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit. Provide leadership to the Devens Validation Engineering FUE, AIQ for Cell Therapy & CSV support of Biologics Clinical and Commercial Manufacturing operations. Develop and implement a strategic approach to ensure a validated and compliant state of operation for systems and equipment through Computer System Validation. Lead the validation execution and quality review of all validation documentation, ensuring external regulatory and internal guidelines and requirements are met.
Key Responsibilities:
Lead the Facilities, Utilities & equipment (FUE), Analytical Instrument qualification (AIQ) and Computer system validation (CSV) validation function for the BMS Devens Manufacturing campus, including FUE & AIQ for Cell Therapy and CSV validation Large Scale Biologics Drug Substance, Single Use Biologics, Cryogenics and supporting Quality Control laboratories.
Oversee validation execution for all engineering projects (small to large).
Establish validation project plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with customers, collaborators, and quality.
Responsibilities include oversight of validation execution work arising from change controls, capital projects, shutdown/changeover activity, and ongoing revalidation programs.
This individual works in conjunction with Quality Assurance to establish appropriate plans and strategies aligned with site validation philosophies. Responsible to deliver validation projects under strict deadlines to ensure customer success. This includes the establishment of plans, protocols, test scripts, risk assessments, and summary reports.
Responsible to act as a validation subject matter expert (SME), serving as the primary point of contact to present validation philosophies and strategies to Health Authority inspectors and auditors.
Establishes specific expectations and objectives to ensure compliance with EHS guidelines, cGMP regulations, Company policies and other external agency regulations.
Supports the development of related procedures and programs, implement and monitor performance.
Identifies areas of opportunity and prepare specific action plans to increase awareness and to maintain compliance.
Keeps oversight of all operations to be executed in a safely manner.
Works collaboratively with Manufacturing Systems, Manufacturing, Manufacturing Engineering, Site Engineering and Quality.
Effectively manages assigned resources to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
Ensure alignment with BMS directives and industry guidelines on validation.
Develops and leads a high performance team responsible for validation execution, manages the recruitment and development of staff, invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition.
Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time.
Responsible for ensuring all regulatory and GxP compliance items related to Validation are satisfied.
Provide significant regulatory inspection readiness training, coaching and guidance to junior level staff/SMEs in validation group.
Manage and develop staff, establish a staffing plan that includes adequate competent resourcing, hiring of key technical individuals as needed, and development and succession planning.
Skills & Experience:
Minimum of 10 years’ experience performing/supporting pharmaceutical application validation in a GMP environment.
Minimum of 7 years’ experience managing personnel and/ or projects.
Thorough knowledge of cGMP in the pharmaceutical industry
Advance experience with equipment, facility, critical utilities validation, and temperature mapping concepts is required.
Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
Expert level knowledge of regulatory validation requirements including FDA, EMA and all other Worldwide Regulatory requirements (ICH Q7, Q8, and Q9) particularly as it applies to biologics / cell therapy manufacturing.
Ability to develop, delegate and motivate others including direct and indirect reports.
Strong financial acumen.
Solid understanding of scheduling fundamentals, execution and cost control.
Advanced understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
Strong multi-tasking ability in conjunction with proven managing skills. Ability to effectively manage multiple projects, initiatives and activities simultaneously. Excels at meeting objective-oriented schedules and timelines.
Excellent interpersonal skills with experience dealing with a diverse workforce.
Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
Strong presentation development and delivery skills.
Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
Ability to create and analyze meaningful metrics.
Excellent project management, communication, and technical writing skills are required.
Understands business needs and synthesizes solutions across functions.
Proven ability working in a matrix environment and leading multi-level / cross-functional teams to achieve the highest performance in meeting site and departmental objectives.
Expert level of problem-solving skills, verbal and written communication skills, and the ability to work independently.
Educational Requirement(s):
Knowledge of engineering generally attained through studies resulting in a Bachelor of Science degree in Chemical Engineering, Mechanical Engineering, related discipline, or its equivalent is required.
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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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