Our client, a leading pharmaceutical company, is hiring a Validation Engineer on a contract basis.
The Equipment Validation Engineer supports the successful implementation of laboratory and manufacturing equipment and utilities 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 workgroup 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.
• Must have CTU temperature mapping experience. Must be familiar with wireless and wired temperature mapping equipment (e.g. Kaye Validator, Ellabs)
• Must have hands on experience with pharmaceutical equipment qualification. Temperature mapping, tube sealers and tube welders, facility and utilities qualification and 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 multitasking 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 an extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
EDUCATION and EXPERIENCE:
• 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 bio/pharmaceutical equipment, facility or utility qualification
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.
• Execution of equipment qualifications and validation protocols for manufacturing and laboratory equipment, utilities and facility
• Temperature mapping of Controlled Temperature Units using wired or wireless mapping systems (e.g. Kaye Validator, Kaye ValProbes, Ellabs, etc.)
• Supervises vendors for qualification functions.
• Develops validation/qualification deliverables such as IOQ Protocols, Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and 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.
• Completes all qualification and validation documentation with accuracy, completeness and compliance to client standards.
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.