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Role Summary
Technical Services Coordinator at a King of Prussia, PA site. Responsible for maintenance of biopharmaceutical GMP equipment and laboratory assets supporting Clinical Supply operations within a manufacturing pilot plant and development laboratories. Manages service providers and third-party contractors, coordinating maintenance activities to support manufacturing and scientific schedules.
Responsibilities
- Equipment Maintenance and Compliance:
- Maintain biopharmaceutical process equipment including laboratory benchtop, analytical, and pilot-scale equipment (e.g., mammalian cell culture single-use bag reactors, stainless steel microbial fermentors, centrifuges, protein purification/filtration systems, CIP systems, equipment washers, autoclaves).
- Coordinate with internal technicians, vendors, and third-party contractors to execute timely maintenance activities to ensure all equipment remains cGMP-compliant and operating safely.
- Scheduling and Coordination:
- Collaborate with stakeholders to proactively plan maintenance around manufacturing and scientific schedules.
- Develop clear scopes of work for vendors and third-party contractors to ensure maintenance tasks are efficiently executed.
- Safety Compliance:
- Manage and generate Safe Work Permits (PTW), Lock-out-Tag-out (LOTO), Hazardous Energy Control Procedures (HECP), and Job Hazard Analysis (JHA) for internal teams, service partners, and third-party contractors.
- Procurement and Documentation:
- Generate purchasing requisitions for parts, maintenance services, and service contracts.
- Follow up on receipt of parts/services and support invoicing processes.
- Troubleshooting and Problem-Solving:
- Support equipment troubleshooting and participate in root-cause analysis for equipment-related failures using Six Sigma tools; provide recommendations to improve preventive maintenance task lists in line with manufacturer recommendations.
- Maintenance Excellence Deliverables:
- Drive a culture of Maintenance Excellence by ensuring efficient processes for planning, scheduling, and executing preventive and corrective maintenance; foster partnerships to identify and implement opportunities for process improvement and long-term reliability.
- AI Integration in Maintenance:
- Explore opportunities to leverage AI tools to enhance predictive maintenance, asset reliability, and maintenance operations; collaborate with cross-functional teams and external partners to evaluate and implement AI-driven solutions.
- Communication and Stakeholder Management:
- Maintain open communication with management and operational areas including Facility Engineers, Maintenance/CMMS Engineers, Process Engineers, Safety Engineers, Manufacturing Operators/Supervisors, Validation specialists, Quality Assurance, Procurement, auditors, and external service contractors (e.g., HVAC, clean utilities, infrastructure, plumbers, automation engineers).
- On-Call Support:
- Provide occasional off-hour on-call support for troubleshooting process equipment and utilities alarms.
Qualifications
- Minimum 4 years of experience in a GMP environment.
- Experience with equipment and systems, including preventive and corrective maintenance.
- Experience with CMMS systems (e.g., EAM, SAP) and Six Sigma tools for root-cause analysis.
- Experience with safety protocols and regulatory compliance requirements.
Preferred Qualifications
- BachelorβΓΓ΄s degree in Engineering, Life Sciences, Business or a related technical field; Vocational Technical School or Military training also highly considered.
- Experience implementing or exploring AI-driven solutions is a plus.
- Experience collaborating across diverse teams and managing multiple priorities.
- Excellent organizational, communication, and problem-solving skills.