Title: GMP Specialist II

Location: Fairfield, NJ area

Schedule: M-F Full Time

Type: Contract

Responsibilities:

Provides GMP engineering services in a pharmaceutical manufacturing factory. Helps prepare and execute documents related to equipment and facility qualification. Contributes to investigations to determine root causes and CAPAs. Manages CAPA’s through completion. Prepares documents for and supports audits by customers or regulatory agencies. Represents Engineering at audits. Performs risk assessments. Performs necessary activities for the Change Control process. Writes SOP’s. Ensures that the engineering document management system complies with GMP and GDP standards. Supports other departments in GMP activities. Implements continuous improvement projects for GMP activities. Maintains global harmonization for Engineering GMP activities.

Performs all Level I items with less supervision. Provides general engineering GMP support to the company by seeking out engineering GMP tasks and other tasks to benefit the company.

• Production Support: Maintains continuity of production by suggesting GMP compliant temporary solutions where necessary to keep production running. Handles minor engineering projects as assigned.

• Department Support: Works some overtime, off-shift and weekend work as necessary to meet deadlines.

• New Business: 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.

• Continuous Improvement: Analyzes current state of Engineering GMP compliance processes and suggests and implements improvement projects.

• Maintenance and Calibration support: Supports maintenance by providing necessary GMP documents. Writes Preventive Maintenance and calibration SOP’s.

• Qualification support: 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.

• Deviation Investigation support: Leads investigations to determine root causes and CAPAs. Manages CAPA’s through completion.

• Audit support: 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.

• Team and Leadership skills: Serves as GMP representative for department.

• Promotes teamwork by establishing and maintaining good relationships with peers.

• Subject Matter Competency: Maintains competency by keeping informed about GMP compliance systems used at other locations and at other similar companies.

  Requirements:

• Bachelors Degree Engineering or Related Field

• 3-4 Years related experience Pharmaceutical/Manufacturing/Related

• Engineer with experience in pharmaceutical manufacturing, process engineering, mechanical engineering, chemistry, bio-technology, electrical engineering, automation engineering or similar studies preferred.

• Excellent Reading, Writing and Verbal Skills

• Computer Skills Intermediate or Advanced in Word, Excel, Power Point

• Excellent Mathematic Skills

• Excellent Team Player, Strong Complaint Resolution Skills

• Able to wear safety glasses, hearing protection, full face/half mask respirator, latex gloves, tyvek suit and other safety equipment as needed.

• Business Dress plus ability to Gown for Manufacturing

• Abide by all cGMP, FDA and DEA regulatory standards

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.