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 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
QualificationsSpecific 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
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.
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 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 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.
