Validation Engineer

Job Title : Validation Engineer Location : Summit, NJ Type : Contract 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.

Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.

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.

Regulatory Responsibilities Ensure equipment, facilities and programs are maintained in compliance. May be called upon as SME in both internal and regulatory audits.

Requirements 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. 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 equipment, facility or utility qualification Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. #M3