Engineering GMP Specialist
- Expired: over a month ago. Applications are no longer accepted.
Location: Fairfield, NJ area
Duration: Direct Hire
Schedule: M-F Full Time
Target Start Date: January 2022
- Provides general engineering GMP support
- Maintains continuity of production by suggesting GMP compliant temporary solutions where necessary to keep production running. Handles minor engineering projects as assigned.
- Supports new business opportunities by serving as project GMP engineering resource and by defining the GMP requirements for new processes, equipment trains and their utility and facility requirements.
- Analyzes current state of Engineering GMP compliance processes and suggests and implements improvement projects.
- Supports maintenance by providing necessary GMP documents. Writes Preventive Maintenance and calibration SOP’s.
- Prepares and executes documents related to equipment and facility qualification such as URS, FAT, SAT, IQ, and OQ protocols. Reviews similar document prepared by internal or external sources.
- Leads investigations to determine root causes and CAPAs. Manages CAPA’s through completion.
- Prepares for audits by collecting and analyzing relevant documents for compliance issues. Maintains document lists or other means to identify documents needed for audits. Develops responses to audit questions. Represents the department face-to-face with auditors.
- Serves as GMP representative for department.
- Promotes teamwork establishing and maintaining good relationships with peers.
- Maintains competency by keeping informed about GMP compliance systems used at other locations and at other similar companies.
- Business Dress plus ability to Gown for Manufacturing
- Minimum Bachelors in engineering or related
- At least 4 years’ experience in pharmaceutical, manufacturing or related field
- Engineer or scientist with experience in pharmaceutical manufacturing, process engineer, mechanical engineer, chemistry, biotechnology, electrical engineering, automation engineer or similar studies preferred
- Excellent mathematics, reading, writing and verbal skills
- Intermediate or advanced in word, power point and excel
- Excellent team player and strong complaint resolution skills
- Ability to wear safety glasses, hearing protection, full face/half mask respirator, latex gloves, Tyvek suit and other safety equipment as needed
- Basic use of tools and equipment
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