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Equipment Commissioning and Qualification Engineer - Summit, United States - Cynet Systems
Description
Job Description:
Pay Range $70hr - $73hr
Responsibilities:
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.
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.
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.
Ensure equipment, facilities and programs are maintained in compliance.
May be called upon as SME in both internal and regulatory audits.
Physical Requirements (Due to the nature of the job):
The candidate should be able to lift 25 pounds with assistance.
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.
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.
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.
Must Haves:
BS in Engineering or Science related discipline required.
5 years
experience performing/supporting activities in a GMP environment.
3 years
experience in equipment, facility or utility qualification.
Environmental Conditions:
Primarily an 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.
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