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The Manager, Sr. Validation Engineer I supports the successful implementation of manufacturing and laboratory equipment at multi-use sites through interaction with internal customers and external service providers.

The incumbent is tasked with qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of medium to high complexity.  With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of moderate scope. As a senior team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

Key Responsibilities:

1. Maintains qualified equipment systems in compliance with policies, guidelines and procedures:

• Executes and/or Leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.

• Ensure periodic reviews and requalification is being performed in accordance with schedule.

• Manage and allocate resources responsible for capital project teams performing validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to existing equipment and standalone/enterprise computerized systems with oversight of department management.

• Author and review the Development/Review of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.

• Execute work arising from change strategy, risk assessment, testing and compliance gaps. 

• Provides Single Point of Contact (SPOC) on all validation activities for a specific manufacturing area in Biologics or Cell Therapy or its supporting areas, working with designated peers to create a team/triage environment.

• For novel projects, this individual works with Quality Assurance, consulting Validation management as needed, to establish appropriate validation methodologies.

• Leads a portfolio of medium to complex validation projects under strict deadlines to ensure stakeholder success and bulk drug supply. Leads projects while serving as an individual contributor of technical work and a point of contact for project stakeholders and cross-functional team members.

• Maintains familiarity on BMS directives and industry guidelines on qualification/validation. Provides, in addition to operations support, internal compliance and/or efficiency improvement efforts within department for more complex processes.

2. Promotes and provides excellent customer service and support

• Regularly reviews, prioritizes, and promptly responds to end user equipment qualification and support requests.

• Provides technical support and guidance on equipment qualification and validations issues.  Interfaces with customers to ensure all expectations are being met.

3. Communication and Management of Timelines

• Executes multiple medium to highly complex projects and priorities across the many portfolios of capital projects that the Validation Engineering organization serves. 

• Develop an effective mechanism for communicating the status of assigned projects all GMP systems maintained by Validation Engineering to all affected stakeholders. 

• Continually seeks opportunities to increase internal stakeholders’ satisfaction and deepen stakeholders’ relationships.

4.Regulatory Responsibilities

• Act as departmental lead and SME in both internal and regulatory audits.

• Performs other duties as assigned.

Knowledge & Skill:

• Ability to execute smaller, but complex technical projects. Demonstrated effectiveness working in both a team environment as well as an individual contributor role.

• Thorough knowledge of cGMP in the pharmaceutical industry.

• Direct experience with equipment, facility, sterilization, commissioning and qualification, critical utilities validation, and temperature mapping concepts is preferred.

• Knowledge of distributed control systems and automation (GAMP) validation concepts suggested.

• 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 experience in designing and implementing quality systems and validation program elements required to manage the validation lifecycle of a fully automated, multi-product, biologics / cell therapy manufacturing facility.

• Highly knowledgeable 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.

• A working understanding of lean principles and six sigma process is preferred.

• Demonstrated high proficiency in project management, communication, and technical writing skills suggested.

• Experienced self-motivated individual who can handle multiple priorities to meet project team goals and timelines.

• Understands business needs and synthesizes solutions across functions.

• The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.

• Provides technical expertise to management.

• Ability to handle difficult and unusual tasks, often using creative problem-solving.

• Working knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines (FDA, EU) and the general understanding to work within a regulatory environment. Knowledge must be demonstrated through previous projects of establishing validation philosophies and regulations at a site level.

• 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.

• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.

• Expert level of problem-solving skills, verbal and written communication skills, and the ability to work independently.

• Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.

Qualifications:

• 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.

• A minimum of 7+ years relevant experience with process equipment, computer systems, manufacturing process control systems (automation) and laboratory instrumentation in an FDA regulated manufacturing facility.

• Minimum of 4 years experience in equipment, facility, or utility qualification

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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 [email protected]. 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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