Senior Validation Engineer
Newark Metro Area, NJ
The Senior Validation Engineer supports the successful operation of facility, laboratory and business functions through interaction with internal customers and external service providers. The incumbent contributes to the completion of specific milestones associated with projects impacting cross-functional teams, supports the department on diverse projects that extend beyond their functional area, and may provide project management leadership on tasks of moderate scope specific to their functional area. With little or no direction, this individual carries out routine tasks and functions. Using analytical skills and expertise, the incumbent independently identifies and solves problems of minor scope and complexity. The individual works collaboratively with their immediate supervisor, team members and internal and external customers to achieve team goals and uses informal leadership opportunities and effective communication to influence team direction and continue to build trust and value.
Maintains all qualified equipment in compliance with policies, guidelines and procedures.
Develops change controls, validation plans, qualification protocols, associated reports and procedures.
Executes equipment qualifications, validation protocols, and process improvement studies.
Schedules and performs periodic field review of qualified systems
Conducts investigations into deviations and qualification failures, and develops and implements corrective and preventive actions
Supports compliance with Facilities Services Qualification Master Plan
Contracts with and supervises vendors for qualification and metrology functions.
Develops and reviews written procedures for calibration and preventive maintenance of equipment.
Coordinates laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
Provides guidance to internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
Supports facilities new construction and relocation projects.
Completes and reviews all calibration, qualification and validation documentation for accuracy, completeness and compliance to standards.
Provides technical knowledge and direction as the site representative during interactions with all cross functional groups, as required.
Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
Provides technical support and guidance on calibration, equipment qualification and validations issues. Interfaces with customers to ensure all expectations are being met.
Maintains a positive relationship with all the members of the department and site customers while promoting a positive team environment.
Maintains all required Corporate, Facilities and EHS training.
Adheres to all safety procedures and hazard communication.
Knowledge, Skills, and Abilities:
CRITICAL ***Must have experience with qualification of the following equipment: Refrigerators, freezers, incubators, welders, sealers, & centrifuges. High proficiency in temperature mapping using Kaye Validator.***
Firm understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
Experience in the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems
Experience writing and executing equipment qualification documents
Experience in managing resources and budgets as required for validation projects
Experience training group members and contractors on procedures, policies and other documents
Ability to interact effectively with laboratory, QA, and Facilities groups
Demonstrates multi-tasking ability in conjunction with solid organizational skills. Strong 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
Strong written and verbal communication skills along with excellent presentation skills. Highly proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation
Highly proficient in Microsoft Office Suite Word, Excel and Outlook, and the innate ability to learn new software as required for equipment qualification.
Technical / Professional Knowledge
Problem Solving / Troubleshooting
Attention to Detail
Occasional stooping, bending, stretching , pushing, pulling, reaching and/or lifting up to 50lbs
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
Ability to climb ladders and work in elevated areas.
Minimal travel in North America
Environment may include working in office or in a laboratory / manufacturing area.
Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
Environment may include working at heights, in cold temperatures, and/or constricted spaces
Ability to work safely when working alone, or working with others.
Education & Experience:
BS degree in Engineering or equivalent
Minimum 5 years of experience in FDA-regulated industry, with 3 years experience in equipment qualification.