Capital Project Engineering Manager

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

PURPOSE AND SCOPE OF POSITION:

The Engineering Manager will be required to lead the engineering department to support the Bristol Myers Squibb, Cell Therapy Development & Operations organization at the Warren, NJ Facility. The Manager of Engineering must support the successful execution of projects for facility, laboratory and clinical manufacturing within the Warren, New Jersey Facility. Through the interaction with internal customers, external A&E service providers and general contractors the incumbent will manage the capital project portfolio for the Warren, NJ Site. By consulting with Site Leadership, the position will manage an effective capital project strategy to meet the product pipeline needs. The role will be required to manage capital requests from internal customers through all phases of project management, including, preliminary planning, detailed design, execution, monitoring and control of capital projects. The role will be expected to execute capital projects of higher complexity directly and manage a project engineering support staff to fulfill the project portfolio according to internal customer’s expectations and priorities

The role is expected to be able to identify issues of unmet needs and initiates projects or programs to address them. This individual works collaboratively to complete assignments and oversees the successful completion of tasks by site leads. As a team leader the incumbent interacts cross functionally and within their own work group to develop and achieve team goals while building trust and collaborative relationships outside the immediate organization.

Using solid analytical skills, the incumbent can recognize problems of significant scope and complexity, and independently, develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.

DUTIES AND RESPONSIBILITIES

Management Responsibilities

Management responsibility for projects includes matrix management of multi-disciplinary, cross-functional site project team members.

Develop and manage the Warren Capital Project program according to Bristol Myer Squibb’s capital project execution standards.

Manages and develops Master Service Agreements and RFPs for preferred A&E Firms, General Contractors, and Equipment Suppliers with Strategic Sourcing.

Oversee the general contractor workforce on site to ensure adherence to all site safety and GMP regulatory requirements.

Oversee the site safety requirements for contractor labor.

Manage project engineering contract support labor force to execute individual projects according to site project portfolio and priorities.

Manage the Engineering Department expense budget.

Manages site CAD system, including the creation, revision and archiving of all project and site drawings.

Capital Planning Responsibilities

Management of Warren Master Plan with Site Leadership Team and Global Engineering.

Develop and manage the capital project budget for the Warren facility, manufacturing and laboratory functions.

Partners with leadership and relevant committees in review and tracking of project with an emphasis on strategy.

Interact cross functionally with groups including but not limited to facilities, qualification, manufacturing, QC, Project Management Office, Site Leadership, MSAT, Global Engineering and Quality Assurance to understand site needs and budget annual capital spend.

Manage the development of feasibility studies to provide Site Leadership with necessary data for decision making.

Work alongside the Facility Reliability group to forecast equipment service life durations for capital planning

Project Management Responsibilities

Develop project management tools to be utilized according to site requirements and BMS Global Engineering Standards.

Generates collaboration, cooperation, and communication across and between functional project team members obtaining buy in of all team members to integrated project strategy.

Manages the development and tracking of detailed project plans, including schedules, cost estimates, resource plans, communication plans, risk mitigation plans, and issue resolution plans.

Identifies and proactively drives high quality project deliverables, dependencies, and critical path items.

Provide routine project portfolio updates on project schedules, budgets and critical path milestones.

Manages project financial reporting and tracking budget to actuals.

Manages the development of project SOWs to include design, equipment purchases, construction, commissioning/qualification and operational readiness deliverables for project RFPs while partnering with Strategic Sourcing.

Proactively manage changes in project scope and create contingency plans in a constantly changing environment.

Manage the identification of potential issues or obstacles and achieves resolution or plans contingencies and follow issues through to resolution ensuring that all team issues arrive at a singular conclusion or recommendation.

Develop risk assessments/FMEAs/HAZOPS during preliminary planning and detailed design phases to confirm proper engineering controls and design needs.

Manage capital project purchase orders and invoicing.

In working with internal cross functional teams including PMO, Equipment Commissioning & Qualification and Manufacturing coordinate and oversee all phases of the capital project schedule.

Communicate, coordinate, and negotiate with internal and external partners on project progress and work with the Management to balance operations execution with project strategy managing through project changes and milestone delays.

Manages project status reporting including development and maintenance of project documents and communication tools.

Provides excellent customer support

Reviews and manages project requests promptly and develops execution plans according to aligned expectations and stage gates.

Provides technical support as SME for project related equipment and facility systems.

Manages turnover documents to support operational readiness including the development of calibration and maintenance plans and operation procedures for new equipment.

Provides support for internal and external regulatory audits in regard to GMP Drawings and technical SME support.

Maintains a positive relationship with all team members and site customers while promoting a positive team environment.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.

Advanced knowledge of pharmaceutical, manufacturing, facility/utility and laboratory systems and equipment that support cell therapy clinical manufacturing.

Project Management Skills including the development and management of work breakdown structures, RACI diagrams, schedules, budgets, action trackers and meeting minutes.

Experience with qualification and commissioning documents

Ability to interact effectively with laboratory, QA, and Facilities groups

Strong understanding of building systems including life-safety, lighting, mechanical, electrical, and plumbing

Knowledge of critical utility systems such as compressed gas, vacuum, waste, as well as security and key managements systems and policies.

Ability to read and understand architectural, MEP and P&ID Drawings

Adept in Microsoft Office Suite – Word, Project, PowerPoint, Excel and Outlook, Visio and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.

Proficient at writing well-formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Ability to follow oral and written instructions, read, interpret and update engineering manuals/drawings relevant to the trade or the assigned task

Self-starter who is able to work both independently without direct supervision or in a team environment

Knowledge of FDA regulations and local building codes

Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced GMP environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.

Experience with technical writing and document development / generation including SOPs, SOWs, RFPs, Work Practices and Maintenance Plans.

EDUCATION AND EXPERIENCE

B.S. degree in Engineering or equivalent;

Project Management Certification or continued education in project management;

2 to 3 years of experience with managing direct reports not required but preferred.

Minimum of 5 years of experience in FDA regulated industry

Minimum 10 years of combined engineering and or capital project management experience.

WORKING CONDITIONS: (US Only) PHYSICAL /MENTAL DEMANDS: (US Only)

This involves physical or mental exertion produced by the incumbent carrying out the responsibilities of the position beyond a standard office environment. This may include the sitting, standing, walking, bending, crawling, climbing, reaching, kneeling, balancing, pushing, pulling, talking, repetitive motion, grasping, lifting or carrying up to 50 lbs. This may also include concentrating, remembering names, distinguishing colors, effective verbal and/or written communication, analytical thinking, decision making, and adapting to change. Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling. Ability to climb ladders and work in elevated spaces.

ENVIRONMENTAL CONDITIONS: (US Only)

Environment may include working in office or in a laboratory / manufacturing or utility/mechanical area.

Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.

Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies

Environment may include working at heights, in cold temperatures, and/or constricted spaces

Ability to work safely when working alone or working with others..

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.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com