Lead Engineer

Bristol-Myers Squibb; Summit (NJ); On-site; USD 88,000 - 107,000; Full time

Benefits offered by this job

Health coverage

401(k) plan

Paid time off

Stock opportunities

Job summary

Bristol Myers Squibb in Summit, NJ, is seeking a Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery to manage commissioning and qualification projects for new equipment, utilities, and facilities at multi-use sites. You will collaborate with internal stakeholders and external vendors to ensure timely, compliant execution.

The role emphasizes project leadership, regulatory compliance (cGMP, 21 CFR 11), and delivering validated systems.

Qualifications

• Knowledge of cGMP, GXP, GAMP, SDLC regulations and 21 CFR 11.
• Experience with qualification/validation in pharmaceutical manufacturing.
• Strong written and verbal communication skills.

Responsibilities

• Lead commissioning and qualification activities for equipment, utilities and facilities.
• Develop qualification protocols and reports.
• Supervise vendors and contract project teams to ensure compliance and on-time delivery.
• Maintain documentation in accordance with BMS standards.

Skills

cGMP

GXP

GAMP

21CFR Part 11

Qualification/Validation

Documentation

Project Management

Communication

Multitasking

Microsoft Office

Education

BS in Engineering or Science

Tools

Microsoft Office Suite

Job description

Working with UsChallenging. 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 SummaryThe 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/ResponsibilitiesCommissioning and Qualification Activities:Maintain qualified equipment systems in compliance with policies, guidelines and proceduresDevelop qualification protocols, and associated reports while adhering to a change management processExecute equipment qualifications and validation protocolsSupervise vendors for qualification functionsSupport development of equipment operational proceduresSupport equipment validation activitiesDevelop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary ReportsSupport Change Management processProject Work Support:Manage equipment implementation projects including scheduling, site prep, installation, qualification, and turn over to business areaSupport internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or datesLead and oversee contract project teams to ensure timely execution and adherence to all compliance and quality requirementsComplete all qualification and validation documentation with accuracy, completeness and compliance to BMS standardsCustomer Service and Support:Regularly review, prioritize and promptly respond to customer equipment qualification and support requestsProvide technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being metProvide technical support and guidance on equipment, utilities, facilities, and computerized systems qualification and validations issuesMaintain a positive relationship with all team members and site customers while promoting a positive team environmentRegulatory Responsibilities:Ensure equipment, facilities and programs are maintained in complianceMay participate in deviation investigations as SMEReporting Relationship: Manager, Senior Manager or Associate DirectorQualificationsSpecific Knowledge, Skills, Abilities:Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practicesKnowledge of pharmaceutical, manufacturing and laboratory systemsUnderstanding of investigations, deviations and CAPA management in a regulated pharmaceutical industryStrong written and verbal communication skillsExcellent interpersonal skills with experience dealing with a diverse workforceStrong multi-tasking ability in conjunction with proven organizational skillsAbility to organize assigned tasks in a high paced environment and concurrently monitor tasks/assignments with others that may impact timely completionAbility to effectively manage multiple tasks and activities simultaneouslyHighly 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 toolsEducation and Experience:BS in Engineering or Science related discipline preferred but can be substituted with sufficient relevant experienceMinimum of 4 years of experience performing/supporting activities in a GMP environmentMinimum of 3 years of experience in equipment, facility or utility qualificationMinimum of 2 years of project management experience in a GMP environmentIf 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.Compensation Overview:Summit West - NJ - US: $88,450 - $107,182The 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 are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: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 OffUS 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 holidaysBased 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: T he 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 CareersWith 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 ProtocolBMS 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 DisabilitiesBMS 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 RightsBMS 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 ProtectionWe 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