Associate, Equipment Commissioning & Qualification (ECQ) Delivery

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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

Key Responsibilities:

Commissioning and Qualification Activities:

• 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.

Project Work Support:

• 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.

Customer Service and Support:

• 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.

Regulatory Responsibilities:

• Ensure equipment, facilities and programs are maintained in compliance.
• May participate in deviation investigations as SME.

Specific Knowledge, Skills, Abilities:

• 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 proficie