Lead Engineer - Summit West, NJ

VetJobs; New Jersey; On-site; USD 75,000 - 100,000; Full time

Job summary

Bristol Myers Squibb in Summit, NJ is seeking a Lead Engineer for Equipment Commissioning and Qualification (ECQ) Delivery. The role supports equipment, utilities, facility, and lab instrument projects at multi-use sites, coordinating with internal and external teams to ensure timely and compliant execution.

Responsibilities include managing qualification projects, developing validation deliverables, and overseeing contract project teams to meet compliance standards.

Qualifications

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11 and computer systems validation requirements.
• Experience with pharmaceutical manufacturing and laboratory systems.
• Strong written and verbal communication skills.

Responsibilities

• Maintain qualified equipment systems in compliance with policies and procedures.
• Develop qualification protocols and reports with change control.
• Manage equipment implementation projects from scheduling to turnover to business area.
• Provide technical support for qualification and validation issues and CAPA management.

Skills

cGMP/GXP knowledge

Project management

Regulatory compliance

Technical communication

Database & data systems

Quality systems understanding

Education

BS in Engineering or Science

Tools

Microsoft Office Suite

Database systems

Job description

Execute Equipment Qualifications And Validation Protocols

Supervise vendors for qualification functions.

Job Description

Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

ATTENTION MILITARY AFFILIATED JOB SEEKERS

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

Auto req ID

480628BR

Minimum Education Required

Bachelors

Qualifications

Additional Qualifications/Responsibilities

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.

City*

Summit West

State*

New Jersey

Job_Category

Engineering

Job Code

Pharmaceutical Pharmaceutical

Affiliate Sponsor

Bristol Myers Sqibb BMS

Salary Range

$75,000-$100,000