Manager, Equipment Commissioning & Qualification (ECQ)
Bristol Myers Squibb
Summary
The Project Engineer/Manager, Equipment Commissioning & Qualification (ECQ) Delivery, ensures the operation of QC laboratories, commercial manufacturing and support services equipment, utilities and facilities at a multi-product site. The role is accountable for coordinating multiple projects and ongoing work activities of moderate to high complexity to ensure on-time and within-budget completion.
Job description
Managerial Responsibilities
- Leads individual contractors or project teams and manages multiple project contractors/project teams simultaneously
- Conducts interviews with external candidates to fill project positions
- Provides direction and motivation to project team members
- Manages workload of project team members and tracks timesheets
- Ensures project team members are appropriately trained for their duties
- Promotes safety of all project team members and adherence to site EHS procedures
- Ensures project team(s) are in full compliance with local, site, and global BMS policies and procedures
Commissioning and Qualification Activities
- Coordinates project execution through effective communication with involved project teams
- Allocates and manages project resources responsible for Commissioning, Qualification, Validation (CQV) activities of equipment, facilities, utilities and laboratory computerized systems
- Manages project teams with emphasis on solutions to technical and compliance challenges across the System Lifecycle
- Oversees development/review/approval of SOPs, WPs, validation deliverables, plans and policies
- Ensures validation resources are knowledgeable of latest industry regulations and initiatives
- Provides input and guidance for change strategy, risk assessment, testing and compliance gaps
Customer Service and Support
- Reviews, prioritizes and promptly responds to customer equipment qualification and support requests
- Provides technical support and guidance on equipment, utilities, facility and computerized systems qualification and validation issues
- Interfaces with customers to ensure expectations are met
- Maintains positive relationships with ECQ department and site customers
Communication and Management of Timelines
- Manages workload of staff across multiple projects and priorities
- Develops and maintains effective communication to keep stakeholders informed of system status
- Continuously seeks opportunities to improve internal client satisfaction and strengthen client relationships
Regulatory Responsibilities
- Ensures equipment, facilities and utilities are maintained in compliance
- Acts as SME in internal and regulatory audits
Requirements
- BS in Engineering or a science-related discipline preferred (substitutable with sufficient relevant experience)
- Minimum of 7 years of experience performing/supporting pharmaceutical application and validation in a GMP environment
- Minimum of 3.5 years of experience managing personnel and/or projects
- Strong understanding of cGMP, GXP, GAMP, SDLC regulations, including 21 CFR Part 11
- Computer systems validation requirements and good documentation practices
- Advanced knowledge of pharmaceutical, manufacturing, and laboratory systems, utilities and equipment
- Skilled in developing project schedules and implementing project plans
- Understanding of cost control
- Ability to train, develop, delegate, and motivate project team members
- Proven experience with investigations, deviations, and CAPA management in a regulated pharmaceutical industry
- Excellent interpersonal skills with experience dealing with a diverse workforce
- Strong multi-tasking ability and proven indirect people management skills
- Ability to effectively manage multiple projects, initiatives, and activities simultaneously
- Strong written and verbal communication skills
- Highly proficient in Microsoft Office Suite
- Proficient in computerized maintenance management validation systems (CMMS), validation systems, task-specific software, and systems
- Ability to create and analyze meaningful metrics, trackers and reports
- Strong instrumentation background and experience in laboratory and manufacturing operations
- Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment
- Thorough knowledge of cGxP in the pharmaceutical industry
- Strong problem-solving skills and ability to work independently
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Time Off
- 11 Paid Company Holidays
- Paid Sick Leave
- Paid Volunteer Days
- Summer Hours Flexibility
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.