Associate, Equipment Commissioning & Qualification (ECQ) Delivery

Bristol Myers Squibb • Summit, NJ

6d • Onsite

About The Position

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. The Associate, Equipment Commissioning & Qualification (ECQ) Delivery supports the successful implementation of equipment, utilities, facility, and lab instruments at multi-use sites through interaction with internal customers and external service providers. The person in this role will support commissioning and qualifying new equipment, facilities and utilities, as well as maintaining equipment systems in a qualified/validated state according to established policies and procedures. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the person in this role interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization. Shift: Mon-Fri: 8AM-5PM

Requirements

• Basic understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Basic understanding of pharmaceutical, manufacturing and laboratory systems.
• 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 prioritize and effectively manage multiple tasks and activities simultaneously.
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook.
• Innate ability to learn new software, such as corporate intranet and enterprise business tools.
• BS in Engineering or Science related discipline preferred, BS/BA required.
• Minimum of 2 years of experience performing/supporting activities in a GMP environment.
• Minimum of 2 years of experience in equipment, facility or utility qualification.

Responsibilities

• Maintain qualified equipment systems in compliance with policies, guidelines and procedures.
• Assist in the development of qualification protocols, and associated reports while adhering to a change management process.
• Participate in execution of equipment qualifications and validation protocols.
• Collaborate with vendors for qualification functions.
• Contribute to equipment qualification/validation activities.
• Aid in the creation of commissioning/qualification deliverables such as, Requirements Specifications, Design Specifications, Commissioning/Qualification protocols, Traceability Matrices, and Summary Reports.
• Support Change Management process.
• Assist with equipment implementation projects including scheduling, site prep, installation, qualification, and turnover 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.
• Complete all qualification and validation documentation with accuracy, completeness and compliance with BMS standards.
• Regularly review, prioritize and promptly respond to customer equipment qualification and support requests.
• Provide troubleshooting assistance on equipment, facilities and utilities commissioning/qualification issues.
• Interface with customers to ensure expectations are being met.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees