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Skills
- Analysis Skillsunmatched
- Biotech and Pharmaceuticalunmatched
- Calibrationunmatched
- Code of Federal Regulationsunmatched
- Computerized Maintenance Management System (CMMS)unmatched
- Cross-Functionalunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Documentationunmatched
- Equipment Maintenance/Repairunmatched
- Establish Prioritiesunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- HVACunmatched
- High School Diplomaunmatched
- Identify Issuesunmatched
- Industry Standardsunmatched
- Inventory Managementunmatched
- Laboratory Equipmentunmatched
- Maintain Complianceunmatched
- Microsoft Officeunmatched
- Microsoft Product Familyunmatched
- OSHAunmatched
- Operating Systemsunmatched
- Operational Supportunmatched
- Pilot Plantunmatched
- Preventative Maintenanceunmatched
- Problem Solving Skillsunmatched
- Process Improvementunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Regulationsunmatched
- Reporting Skillsunmatched
- Research & Development (R&D)unmatched
- Safety Standardsunmatched
- Standard Operating Procedures (SOP)unmatched
- System Operationsunmatched
- Team Playerunmatched
- Test Plan/Scheduleunmatched
- User Groupsunmatched
- Water For Injection (WFI)unmatched
Description
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
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
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.
- 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
Numbers & Facts
| Location | Exton, Pennsylvania |
| Industry | Staffing/Employment Agencies |
| Company Size | 2,500 to 4,999 employees |
| Website | https://systemone.com |
About Company
Every day, System One focuses on services and solutions that require a high degree of specialization, in-demand technical skills, and large-scale operational expertise. We are essential partners to those on the front lines of our nation’s most critical infrastructure, technology, and life sciences initiatives.
Founded more than 40 years ago as a staffing partner to the engineering industry, today System One is a diversified organization operating in over 50 locations and putting more than 9,000 people to work in the United States, Canada, and the United Kingdom.
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