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Equipment Commissioning - Summit, United States - Aequor Technologies
Description
100% onsiteMust Haves:
BS in Engineering or Science related discipline required
Minimum of 5 years' experience performing/supporting activities in
a GMP environment.
Minimum of 3 years' experience in equipment, facility or utility
qualification
Job Description: 100% onsite
The Equipment Validation Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers.
commissioning and qualifying new equipment facilities, utilities and 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 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.
REQUIRED COMPETENCIES:
Knowledge, Skills, and Abilities:
Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
Experience in the qualification of cell therapy equipment a plus
Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
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.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.
DUTIES AND RESPONSIBILITIES:
1)
Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
Develops qualification protocols, and associated reports while adhering to a change management process.
Supports the execution of equipment qualifications and validation protocols.
Supervises vendors for qualification functions.
Develops written procedures for calibration and preventive maintenance of equipment.
Supports equipment qualification and validation activities.
Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
2)
Manages projects of limited scope and complexity within their functional area:
Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
3)
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 qualification issues. Interfaces with customers to ensure all expectations are being met.
Provides technical support and guidance on equipment and computer systems qualification and validations issues.
Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
4) Regulatory Responsibilities
Ensure equipment, facilities and programs are maintained in compliance.
May be called upon as SME in both internal and regulatory audits.
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.
Additional Job Requirements:
None
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