• 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:
The Equipment Validation Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers.
The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures.
The individual participates in projects and ongoing work activities of low to moderate complexity.
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:
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.