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Facilities Engineer
1 month ago
Summary
DPS Group has an excellent opportunity for a Facilities Engineer to join our team in supporting our world-class, innovative BioPharma client in the Central, NJ area.
Responsibilities
- Equipment Commissioning, Qualification, Validation.
- Facilities/Utilities experience
- Manufacturing Room Qualification
- AHU's
- Process Air and Carbon Dioxide Lines
- Support project Equipment Validation (i.e. autoclave, bioreactor) – Lab/cGMP.
- Familiarity with the user, functional, installation, operation, and performance requirements for assigned projects and tasks.
- Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications), for use in the development of equipment commissioning and validation documents
- Equipment validation protocol development, including drafting documents, managing review cycles and protocol approval.
- Support Validation Master Plan development
- Execution of equipment validation protocols (including use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.)
- Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval.
- Support Validation Summary Report development
- Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system).
- Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation.
- Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.).
- Support resolution of engineering/validation issues found during equipment validation.
- Attending meetings as required to support equipment installation and operation
- Providing quality oversight and approval for validation documents as needed. (Function test, IQs, OQs, etc…)
- Support developing SOP’s
- Other tasks as requested or required to support the project
- Other duties as assigned
Skills and Qualifications
- Bachelor's degree in mechanical engineering or related engineering major
- 2-7 years validation/facilities/utilities experience
- Equipment Validation/CQV experience working within a cGMP & FDA Regulated environment is preferred.
- A strong understanding and knowledge of equipment and automated systems
- Previous experience working in a cGMP and FDA regulated environment
- Performs other duties as assigned by management.
- Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
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