Manager, Equipment Commissioning & Qualification (ECQ)

About the role

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 Project Engineer/Manager will be accountable for coordinating multiple projects and ongoing work activities of moderate to high complexity to ensure on-time and within-budget completion.

In addition to project coordination, scheduling, and managing project staff, the role also involves spending a small portion of time on individual work.

Shift: Mon-Fri: 8AM-5PM

Managerial Responsibilities

• Leads individual contractors or project teams. Should be able to manage multiple project contractors/project teams simultaneously.
• Conducts interviews with external candidates to fill project positions.
• Provides direction and motivation to project team members.
• Manages the workload of project team members to ensure appropriate work-life balance and track their timesheets.
• Ensures that project team members are appropriately trained for their duties.
• Promotes and ensure the safety of all project team members and adherence to site EHS procedures and guidelines.
• Ensures that project team(s) are in full compliance with local, site, and global BMS policies and procedures.
• Commissioning and Qualification Activities:
• Coordinates project execution by effective communication with involved project teams.
• Allocates and m/anage project resources responsible for performance of 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 in all phases of the System Lifecycle.
• Oversees the development/review/approval of SOPs, WPs, validation deliverables, plans and policies as needed.
• Ensures resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.
• Provides input and guidance for change strategy, risk assessment, testing and compliance gaps.
• Customer Service and Support:
• Regularly 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 validations issues.
• Interfaces with customers to ensure all expectations are being met.
• Maintains a positive relationship with all the members of the ECQ department and site customers while promoting a positive team environment.
• Communication and Management of Timelines:
• Manages the workload of staff across multiple projects and priorities in the various departments served by the ECQ organization.
• Develops and maintain an effective communication mechanism to keep all affected stakeholders informed about the current status of all systems maintained by ECQ.
• Continuously seeks opportunities to improve internal client satisfaction and strengthen client relationships.
• Regulatory Responsibilities:
• Ensures equipment, facilities and utilities are maintained in compliance.
• Act as SME in both internal and regulatory audits.
• Specific Knowledge, Skills, Abilities:
• 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.
• Ability to organize and coordinate assigned tasks in a fast-paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
• Excels at meeting objective-oriented schedules and timelines.
• Strong written and verbal communication skills.
• Highly proficient in Microsoft Office Suite.
• Innate ability to learn new software, such as corporate intranet and enterprise business.
• 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.
• Education and Experience:
• BS in Engineering or a science-related discipline is preferred but can be substituted 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 instrumentation background and experience in laboratory and manufacturing operations.
• Experience interacting with regulatory agents, external and/or internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions.
• Thorough knowledge of cGxP in the pharmaceutical industry
• Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
• Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
• Working Conditions:
• 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.
• Primarily an office environment. Will be required to enter laboratories 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.

Additional information

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.

Compensation Overview

Summit West - NJ - US: $106,630 - $129,214

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

How We Work

• Where you work matters - because collaboration, innovation and patient impact happen in many settings.
• Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design.
• The model assigned to this role is based on its core responsibilities.

Data Protection

• We will never request payments, financial information, or social security numbers during our application or recruitment process.
• Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

• If this posting is missing required information required by local law or incorrect, contact BMS at with the Job Title and Requisition number.
• Do not send application-related inquiries to this email.
• To check your application status, please login to your Candidate Home Account.

R1608357: Manager, Equipment Commissioning & Qualification (ECQ)