Manager, Equipment Commissioning and Qualification Delivery and Operations

Job Description

Req #: 1903770
Location: Warren, New Jersey, United States
Job Category: Facilities
Work Location: 7 Powder Horn Drive 07059
Organization: Facilities Engineering
Employee Status: Full-time
Job Type: Regular

Purpose of the Position:
The Manager, Equipment Commissioning & Qualification Delivery supports the successful operation of facility, laboratory and business functions at multi‐use sites through interaction with internal team members and peer‐level customers as well as external service providers. The incumbent in this role manages supervisors or associate managers who are leading entry, junior, and experienced level professionals to accomplish daily tasks and short‐term projects according to established policies and procedures. The individual will oversee teams leading multiple projects and ongoing work activities of low to moderate complexity to ensure on time and within budget completion. In addition to answering questions and resolving issues for staff, the incumbent spends a small portion of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit.

Essential Functions:
Management Responsibilities:
Lead a larger team of up to 20 people, including 2 supervisors.
Interview and hire internal and / or external personnel to fill necessary roles.
Provide direction to internal and external team members.
Manage the workload of team members to ensure appropriate work life balance.
Delegate, develop and motivate direct and contract reports.
Set departmental and individual goals.
Deliver personnel performance reviews.
Ensure team members are appropriately trained for duties being performed.
Assist in the preparation of departmental operational expense and capital budgets. Justify and work within approved headcount.
Promote and ensure the safety of all team members and adherence to site EHS procedures and guidelines.
Ensure the team is in full compliance with local, site and global Celgene policies and procedures.
Ensure the team is properly staffed and is technically competent to support the various equipment technologies and groups here at Celgene.
Commissioning and Qualification Activities
Manage Equipment Commissioning & Qualification equipment qualification and computerized system validation teams.
Manage and allocate resources responsible for teams performing validation activities of new equipment and standalone/enterprise laboratory computerized systems and/or changes to existing equipment and standalone/enterprise computerized systems.
Define the needs, benefits, and technical strategy within the project life-cycle and overall processes.
Manage project teams with emphasis on solutions to technical and compliance challenges in all phases of the System Lifecycle.
Oversee the Development/Review/Approval of SOPs, WPs, test protocols, validation deliverables, plans and policies as needed.
Maintain departmental commissioning and qualification procedures and policies. Ensure site and project master plans comply with global policies and regulatory agency requirements.
Ensure resources performing validation activities are knowledgeable of and in tune with latest industry regulations and initiatives.
Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
Ensures compliance with Facilities Services Qualification Master Plan
Responsible for developing and managing budgets and resources for the program.
Assist with the creation of departmental metrics. Understand and review departmental metrics, deliver to the team and use to determine areas for improvement.
Operational Activities
Manage Equipment Commissioning & Qualification operations staff including the scheduling, execution, and documentation of calibration, maintenance, repair, and equipment requalification activities in both laboratory and manufacturing areas in Summit facilities.
Support the review and approve calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to Celgene standards.
Supports investigations into deviations and qualification failures, and develops and implements corrective and preventive actions
Ensures compliance with Facilities Services Qualification Master Plan
Reviews and approves written procedures for calibration and preventive maintenance of equipment.
Maintain the calibration management system in a validated state.
Provide oversight to: the management of the stability test chambers, the monitoring of all validated environmental monitoring systems, and the calibration of all test equipment used by Metrology during the execution of their duties.
Assist senior management in managing budgets and resources for the program.
Assist with the creation of departmental metrics. Understand and review departmental metrics, deliver to the team and use to determine areas for improvement.
Promotes and provides excellent customer service and support
Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on equipment and computer systems qualification and validations issues. Interfaces with customers to ensure all expectations are being met.
Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met.
Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
Communication and Management of Timelines
Manage staff workload of multiple complex projects and priorities across the many different departments that the ECQ organization serves.
Develop an effective mechanism for communicating the current status of all laboratory systems maintained by ECQ to all affected stakeholders.
Communicate effectively with peers and senior management to identify needs, justifications, and evaluate alternative business solutions when appropriate.
Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
Represent ECQ at site leadership team. Deliver presentations at site all hands and pizza lunches.
Inventory Management Work with planning group to ensure system is updated as calibration, maintenance, qualification and requalification activities are performed.
Service Contract Support Assist with the management of Vendor service contracts to support equipment and systems. Provide feedback to departmental leadership on vendor performance and needs.
Regulatory Responsibilities
Ensure equipment, facilities and programs are maintained in compliance.
Act as departmental lead and SME in both internal and regulatory audits.
Required Competencies‐Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:

• Expert knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
• Ability to develop, delegate and motivate others including direct and indirect reports.
• Strong financial acumen.
• Solid understanding of scheduling fundamentals, execution and cost control.
• Advanced understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
• Strong multi-tasking ability in conjunction with proven managing skills. Ability to effectively manage multiple projects, initiatives and activities simultaneously. Excels at meeting objective-oriented schedules and timelines.
• 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.
• Strong presentation development and delivery skills.
• 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.
• Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM.
• Ability to create and analyze meaningful metrics.
• Experience with departmental capital and expense budget forecasting and management.

Competencies:

• Professional Knowledge
• Problem Solving
• Team Player / Building Relationships
• Multi‐tasking
• Customer Focus
• Action and detail oriented
• Active Listening
• Decisive

Education & Experience:

• BS in Engineering or Science related discipline preferred.
• Minimum of 10 years’ experience in a GMP environment.
• Minimum of 7 years’ experience performing/supporting pharmaceutical application validation in a GMP environment.
• Minimum of 5 years’ experience managing personnel and/ or projects.
• 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 cGMP in the pharmaceutical industry.
• Advanced computer skills and demonstrated knowledge of validating computer systems used 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.
• Strong instrumentation background and experience in laboratory and manufacturing operations.
• 5 years of maintenance coordinating / planning experience, preferably in a laboratory environment.

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 office environment, but 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.
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COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.