JT562 - SR MANUFACTURING ENGINEER
About The Position
Quality Consulting Group is seeking a highly motivated Senior Manufacturing Engineer to join its team supporting the pharmaceutical, biotech, medical device, and manufacturing industries in Puerto Rico and the USA. The role leads complex equipment lifecycle projects in regulated manufacturing environments, including procurement support, equipment relocation and installation readiness, qualification and validation, cleanroom and layout changes, change control updates, and decommissioning. The successful candidate will work under tight timelines and shifting priorities while ensuring manufacturing processes and procedures comply with applicable regulations.
Requirements
- Bachelor's degree in engineering.
- At least 4 years of experience in a related area.
- Experience executing manufacturing equipment moves, installations, commissioning, startup, and decommissioning activities.
- Knowledge of facility utilities, equipment integration, and manufacturing readiness activities.
- Strong experience with equipment qualification (IQ/CSV/OQ/PQ), process validation, cleaning validation, and cleanroom qualification.
- Familiarity with GMP requirements, change control, risk assessments, and maintaining validated state following equipment or facility changes.
- Experience supporting manufacturing layout changes, facility modifications, and material and personnel flow assessments.
- Ability to evaluate facility, utility, and environmental requirements for regulated manufacturing operations.
- Availability for first shift.
Responsibilities
- Support equipment relocation, installation, and decommissioning.
- Perform process validation.
- Manage manufacturing process and facility changes.
- Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
- Design machine arrangements within plant facilities to promote efficient and productive layouts.
- Design operation sequences and specify fabrication procedures for tools, equipment, and other functions affecting product performance.
- Adapt machine and equipment designs to factory and production conditions, incorporating inspection and testing requirements into production plans as needed.
- Inspect machinery, equipment, and tools for performance and efficiency, investigate problems and deficiencies, and initiate corrective actions to ensure product quality.
- Develop manufacturing processes applicable to statistical process control and potentially develop related techniques.
- Guide engineering teams on design concepts and specification requirements to optimize equipment use and manufacturing techniques.
- Ensure processes and procedures comply with regulations.
- Support equipment moves, installations, commissioning, startup, and decommissioning activities.
- Support equipment qualification, process validation, cleaning validation, and cleanroom qualification.
- Maintain the validated state following equipment or facility changes, including through change control and risk assessments.
- Support manufacturing layout changes and facility modifications, including material and personnel flow assessments.
- Evaluate facility, utility, and environmental requirements for regulated manufacturing operations.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
