Purpose of the Position:

The Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports the successful configuration, implementation and support of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. With minimum supervision and given general instructions, this individual carries out routine tasks and functions and uses strong analytical skills to recognize and solve challenging problems of various degrees of complexity and scope. As a developing team player, the incumbent 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.

The Lead CSV Engineer, through hands-on leadership, will be directly responsible for individual efforts, projects and other tasks. The incumbent will be responsible for fostering a productive, learning environment for colleagues and reports while ensuring timely completion of assigned work.

Essential Functions:

Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures:

• Applies strong technical skillset to investigate and resolve complex challenges.
  
  • Investigate and resolve Deviations, CAPA investigations and other potential issues.
• Supports equipment qualification and validation activities.
• Configure and document the configuration of computerized systems to meet the requirements of CFR21 Part 11.
• Supports the execution of equipment qualifications and validation protocols
• Supervises vendors for qualification functions.
• Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
• Responsible for the delivery of all lifecycle deliverables in the Qualification of equipment and full CSV for single and multi-user Computerized Systems.
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.

Initiates, manages and leads projects of moderate scope and complexity within their functional area.

• Manages projects of varying scope and complexity.
• Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.
• Author quality procedures and training documents
• Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners.
• Innovate, research and develop tools and solutions to provide more efficient and compliant solutions for department use and deployment.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
• Support growing standardization efforts in the review and approval of Validation Deliverables

Promotes and provides excellent customer service and support

• Provides excellent customer service and support.
• Regularly reviews, prioritizes and promptly responds to customer qualification, validation and support requests.
• Provides technical support and guidance on Validation, Quality Process and equipment qualification issues. Interfaces with customers to ensure all expectations are being met.

Regulatory Responsibilities

• Ensure equipment, facilities and programs are maintained in compliance.
• Act as departmental delegate and SME in both internal and regulatory audits.

Required Competencies-Knowledge, Skills, and Abilities:

Knowledge, Skills & Abilities:

• Strong working knowledge of MS Windows client and server technologies including user groups, folder permissions and windows policies.
• Ability to learn new technologies while applying a strong technical skillset to configure computerized systems to meet Business and Regulatory requirements.
• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
• Strong working knowledge of SDLC principles and standards
• Ability to work with the end user to identify and document User and Functional Requirements
• Knowledge of pharmaceutical laboratory and manufacturing systems.
• Experience authoring and executing standard CSV deliverables
• Ability to interact effectively with manufacturing, laboratory, QA, and Facilities groups
• Strong 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
• Strong written and verbal communication skills along solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
• Strong computer skills in Microsoft Office Suite - Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Competencies:

• Technical / Professional Knowledge
• Problem Solving / Troubleshooting
• Action Oriented
• Attention to Detail
• Multi-tasking
• Building Relationships

Education & Experience:

• BS degree or equivalent experience
• Minimum 5 years of experience in FDA-regulated industry

Working Conditions:

Physical / Mental Demands:

• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.

Environmental Conditions:

• Primarily an office environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
• Ability to work safely and effectively when working alone or working with others.

Compensation Overview:

Summit West - NJ - US: $86,490 - $104,803

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.

On-site Protocol

BMS 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.