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Position: Associate Director – Capital Projects / C&Q / Shutdown ProgramLocation: Manatí, PR

Key Responsibilities

Manages the development and administration of operating expense and capital spending budgets for the Engineering organization within the Facilities & Engineering department.Direct management of Commissioning & Qualification (C&Q) teams. Provide strategic oversight and direct management of the Commissioning & Qualification processes for equipment qualification and computerized system validation teams associated with capital project assets. This includes managing contracted resources to ensure that all C&Q activities are executed to the highest standards of quality and compliance.Lead and mentor a multidisciplinary team of colleagues and contractors to achieve C&Q objectives that are aligned with capital project milestones and overall site goals. Foster a collaborative and high-performance culture to drive successful project outcomes.Develop comprehensive Scope of Work (SOW) documents and manage the bidding process to contract C&Q resources. This involves detailed project planning, resource loading, and defining project deliverables to support the implementation of the site capital plan.Ensure that all contracted resources are aligned with project timelines, budget constraints, and quality standards, and oversee the integration of these resources into the broader project framework.Lead and coordinate site shutdown resource. Strategically manage and allocate contracted resources to develop and execute comprehensive site shutdown activities.This includes detailed planning, resource allocation, and coordination with various departments to ensure seamless integration and execution of shutdown tasks.Ensure rigorous planning, execution and reporting of shutdown activities. Guarantee that all shutdown activities are meticulously planned and executed in alignment with the project plan.This involves developing detailed shutdown schedules, risk assessments, and contingency plans, as well as monitoring progress to ensure adherence to timelines, budget constraints, global & site procedures, and quality standards.Conduct post-shutdown reviews to identify areas for improvement and implement best practices for future shutdowns.Communicates a clear vision aligned with Site and overall business objectives. Develops and implements state of the art engineering systems (for the Project Engineering section) and manages the capital plan and engineering staff for projects at the Manatí site.Capital project management entails all phases including project scope development, design, securing of all permits, construction management and commissioning and qualification.Provides engineering support to the operational and maintenance teams within the specific systems they own.Develops and implement performance targets for Engineering that creates a commitment to superior quality and Safety from the staff. Respects diversity and develops relationships with diverse groups across the client base at the Manatí site.Works within a team environment with other Facilities & Engineering functions, including Maintenance & Reliability, and Facilities Services in a matrix organization. As a member of the Facilities & Engineering team, will initiate projects together with other functional groups and review engineering drawings and specifications.Oversee the development, review, and approval of key documentation. Supervise the creation, review, and approval of Standard Operating Procedures (SOPs), Work Procedures (WPs), test protocols, validation deliverables, plans, and policies as required.Ensure that all documentation meets the highest standards of quality and compliance and is aligned with project and organizational objectives.Ensure the continuous maintenance and updating of departmental commissioning, qualification, and maintenance procedures and policies.This includes regular reviews to incorporate best practices, regulatory changes, and technological advancements.Guarantee that site and project master plans are in full compliance with global policies and regulatory agency requirements.This involves staying abreast of the latest regulatory developments, conducting regular audits, and implementing necessary changes to maintain compliance and operational excellence.Builds and sustain strong relationships with internal and external stakeholders including Manufacturing, Quality, EHS, and local community and regulatory agencies to meet site and Business requirements.Periodically will assess with the customer that expected service level is being attained and must strive to exceed such expectations.Will interface with regulatory bodies and be accountable for non-conformance investigation thoroughness with appropriate and timely CAPA implementation. Ensures compliance with plant safety regulations and environmental regulatory requirements.Manages Site Development Master Plan in support of operational needs and business strategy. Provide strategic support to the Manatí Site Project Management Office (PMO) by managing and aligning the project portfolio with the site's prioritization strategy.This includes evaluating project proposals, ensuring resource allocation aligns with strategic priorities, and monitoring project progress to ensure alignment with site goals and objectives.Collaborate with cross-functional teams to ensure that all projects are executed efficiently and deliver maximum value to the organization.

Qualifications & Experience
 

Bachelor’s degree in engineering.Minimum 10 years of experience in Engineering within the Pharmaceutical industry.Experience working within a biologics pharmaceutical processes and engineering design. Understanding of engineering management processes.Understanding of building maintenance activities and functions, capital project engineering, commissioning, and qualification.Knowledge of utilities, alternative energy sources such as cogeneration, energy supply and demand.Ability to formulate, clearly communicate and implement the strategy for the engineering organization, one that will integrate supporting functions to the engineering process.Engineering design knowledge of clean utilities, water for injection, pure steam, clean room technology.Broad knowledge of Biologics Drug Product Process Design, Good Manufacturing Practices, governing building codes, OSHA and EPA regulations, and industry regulations related to the manufacture of pharmaceutical products. Working knowledge of FDA regulations, fundamental principles, and operating implementation for electrical, HVAC, process heating and cooling utilities. Ability to manage or be an active team member of cross-functional project teams. Strong time management skills, planning and organization capabilities. Mastery on project management skills Proven ability to influence and lead other engineers/contractors towards the execution of position objectives.Excellent Technical Writing/Oral communication skills (English/Spanish) Proven assessment, analytical and problem-solving skillsHighly 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. Strong presentation skills.

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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.

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