Process Mechanic

Job Title : Process Mechanic
Location : Exton, PA
Type: Contract

Overview
The Process Mechanic is responsible for monitoring, operation, performing preventive maintenance and corrective maintenance of GMP and non-GMP utilities and HVAC equipment as well as process related equipment.

Responsibilities

• Maintain GMP and non-GMP utilities related to the pilot plant and R&D facility.
• Perform preventive and corrective maintenance on process related equipment. Maintains spare parts inventory for critical equipment.
• Schedule preventive maintenance and corrective work orders working with user groups.
• Develop and adhere to all SOPs and other GMP documentation as required.
• Monitor activities of outside contractors supporting maintenance and calibration activities.
• Participate in planning and process improvement activities at the departmental and inter-functional level.
• Ensure adherence of operations to cGMP as well as industry safety standards and OSHA guidelines.
• Interact cross-functionally with Downstream/Upstream Operations, Support Operations, Quality Assurance, Quality Control, Validation, and other internal and external functions and the R&D Facility.
• System operation includes, but is not limited to, plant steam, clean steam, chilled water, cooling towers, compressed air systems, and pharmaceutical grade water systems (WFI water) equipment under GMP operation.
• Analyzes results and may develop testing and maintenance specification on new and existing equipment.
• Prepare reports with recommendations for solutions to technical problems.

Requirements

• High School Diploma required, Associates Degree or equivalent experience preferred.
• A minimum of 5 years working experience in a cGMP Facilities department in a FDA-regulated industry with Associates Degree, or a minimum of 7 years working experience in a cGMP Facilities department in a FDA-regulated industry with High School Diploma.
• Prior experience in a GMP plant and experience with 21 CFR Part 11.
• Knowledge of cGMP/EMEA and JP regulations.
• Experience with inspections/audits by the FDA or other similar regulatory agencies.
• Experience with CMMS software.
• Working knowledge of Microsoft operating systems and proficiency in MS Office applications.
• Ability to prioritize and successfully manage complex and competing projects.
• Demonstrated ability to deliver effective troubleshooting solutions under tight timelines and delivery pressures while maintaining composure and strong performance.
• Limited handling of laboratory equipment, chemicals, and biological materials
• This position will require weekend on-call rotation and some off-hour emergency response.

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions 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 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.