Lead Engineer

Bristol Myers Squibb EU Policy; South Hadley Falls (MA); On-site; USD 88,000 - 107,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) Plan

Job summary

Bristol Myers Squibb is seeking a Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery to drive commissioning and qualification of new equipment, utilities, facilities and lab instruments at multi-use sites. You will work with internal stakeholders and external vendors to ensure on-time, compliant execution.

With minimal supervision, you will manage qualification projects, develop protocols, supervise vendors, and ensure final qualification and validation deliverables meet BMS

Qualifications

• BS in Engineering or science; relevant experience accepted.
• Minimum 4 years GMP experience.
• Minimum 3 years equipment/utility qualification.
• Minimum 2 years GMP project management experience.

Responsibilities

• Maintain qualified equipment systems in compliance with policies and procedures.
• Develop qualification protocols and associated reports.
• Execute equipment qualifications and validation protocols.
• Supervise vendors for qualification functions.
• Support development of equipment operational procedures.
• Support equipment validation activities.
• Develop validation/qualification deliverables and reports.
• Support Change Management processes.
• Manage equipment implementation projects: scheduling, site prep, installation, and turnover.
• Lead internal customers in operation, calibration and maintenance.
• Oversee contract project teams to ensure timely, compliant execution.
• Complete all qualification/validation documentation accurately.

Skills

cGMP/GXP knowledge

Pharma/manufacturing systems

CAPA & investigations

Communication skills

Interpersonal skills

multitasking & organization

Office software proficiency

Task management in GMP

Education

B.S. in Engineering or related

4+ years GMP experience

3+ years equipment/utility qualification

2+ years GMP project management

Job description

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. 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.

Position Summary

The Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery, plays a key role in supporting the successful implementation of equipment, utilities, facility, and laboratory instrument projects at multi-use sites. This position involves close collaboration with internal stakeholders and external service providers to ensure timely and compliant execution.

The individual in this role is responsible for managing commissioning and qualification projects for new equipment, utilities, and facilities, as well as maintaining existing systems in a qualified and validated state in accordance with established policies and procedures.

With minimal supervision and general guidance, the Lead Project Engineer performs routine tasks and applies foundational project management and analytical skills to identify and resolve problems of limited scope.

As a developing team leader, this person works closely with their supervisor and team to meet project goals while building strong relationships with other departments. They will also be responsible for managing contract project teams to ensure work is completed on time and in compliance with requirements.

Duties / Responsibilities

Commissioning and Qualification Activities

• Maintain qualified equipment systems in compliance with policies, guidelines and procedures
• Develop qualification protocols, and associated reports while adhering to a change management process
• Execute equipment qualifications and validation protocols
• Supervise vendors for qualification functions
• Support development of equipment operational procedures
• Support equipment validation activities
• Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports
• Support Change Management process

Project Work Support

• Manage equipment implementation projects including scheduling, site prep, installation, qualification, and turn over to business area
• Support internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates
• Lead and oversee contract project teams to ensure timely execution and adherence to all compliance and quality requirements
• Complete all qualification and validation documentation with accuracy, completeness and compliance to BMS standards

Customer Service And Support

• Regularly review, prioritize and promptly respond to customer equipment qualification and support requests
• Provide technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met
• Provide technical support and guidance on equipment, utilities, facilities, and computerized systems qualification and validations issues
• Maintain a positive relationship with all team members and site customers while promoting a positive team environment

Regulatory Responsibilities

• Ensure equipment, facilities and programs are maintained in compliance
• May participate in deviation investigations as SME

Reporting Relationship: Manager, Senior Manager or Associate Director

Qualifications

Specific Knowledge, Skills, Abilities

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices
• Knowledge of pharmaceutical, manufacturing and laboratory systems
• Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry
• Strong written and verbal communication skills
• 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
• 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 tools

Education And Experience

• BS in Engineering or Science related discipline preferred but can be substituted with sufficient relevant experience
• Minimum of 4 years of experience performing/supporting activities in a GMP environment
• Minimum of 3 years of experience in equipment, facility or utility qualification
• Minimum of 2 years of project management experience in a GMP environment

Compensation Overview

Summit West - NJ - US: $88,450 - $107,182

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit Offerings

• Health Coverage: Medical, pharmacy, dental and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life Benefits Include

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

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 a supportive culture, promoting global participation 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 An 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.

Supporting People With Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at [e-mail]. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1604656 : Lead Engineer