What are the responsibilities and job description for the Lead Project Engineer, Equipment Commissioning and Qualification (ECQ) in Summit, NJ position at Bristol Myers Squibb?
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The Lead Project 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.
Responsibilities:
- 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.
- 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.
- 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.
- Ensure equipment, facilities and programs are maintained in compliance.
- May participate in deviation investigations as SME.
Knowledge & Skills:
- 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.
Basic Requirements:
- 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.
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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.
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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 an inclusive culture, promoting diversity 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 a diverse 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.
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