Job Title: Senior Validation Engineer
Location: Warren, New Jersey
Duration: One year from start date
Hours: 8am to 5pm (some flexibility) 40 hrs/week
- 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.
- 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 all required Corporate, Facilities and EHS training.
- Adheres to all safety procedures and hazard communication.
Required Competencies-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.
Education & Experience:
- BS degree in Engineering or equivalent
- Minimum 5 years of experience in FDA-regulated industry, with 3 years experience in equipment qualification.
Sthree US is acting as an Employment Business in relation to this vacancy.