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Role Summary
As Technical Services Coordinator, you will play a critical role in ensuring the maintenance of biopharmaceutical GMP equipment and laboratory assets that support Clinical Supply operations within a manufacturing pilot plant and development laboratories. Working within the R&D Engineering Department as part of the Technical Services and Facilities team, you will be accountable for managing service providers and third-party contractors, coordinating work to ensure maintenance is conducted efficiently and effectively to support manufacturing and scientific schedules. This is a full-time onsite role at our King of Prussia site in the US.
Responsibilities
- Equipment Maintenance and Compliance
- Maintain a variety of biopharmaceutical process equipment, including laboratory benchtop, analytical equipment and pilot scale equipment such as mammalian cell culture single-use bag reactors, stainless steel microbial fermentors, centrifuges, protein purification/filtration systems, CIP systems, equipment washers, and 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 activities 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 efforts and participate in root-cause analysis for equipment-related failures using Six Sigma tools to address safety and quality investigations.
- Provide recommendations to improve preventive maintenance task lists, ensuring alignment with equipment manufacturer recommendations.
- Maintenance Excellence Deliverables
- Drive a culture of Maintenance Excellence by ensuring efficient processes for planning, scheduling, and executing preventative and corrective maintenance activities.
- Foster partnership with internal teams and external vendors to identify then implement opportunities for process improvement and long-term reliability.
- AI Integration in Maintenance
- Explore opportunities for leveraging Artificial Intelligence (AI) tools to enhance predictive maintenance capabilities, improve asset reliability, and streamline maintenance operations.
- Collaborate with cross-functional teams and external partners to evaluate and implement AI-driven solutions for maintenance optimization.
- Communication and Stakeholder Management
- Maintain open communication channels with management and operational areas, including Facility Engineers, Maintenance/CMMS Engineers, Process Engineers, Safety Engineers, Manufacturing Operators/Supervisors, Validation specialists, Quality Assurance colleagues, Procurement, auditors, and third-party 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
- Required: Minimum 4 years of experience working within a GMP environment.
- Required: Experience with equipment and systems, including preventive and corrective maintenance practices.
- Required: Experience with CMMS systems (e.g., EAM, SAP) and Six Sigma tools for root-cause analysis.
- Required: Experience working collaboratively across diverse teams and managing multiple priorities.
- Required: Experience with safety protocols, and regulatory compliance requirements.
- Preferred: Experience with implementing or exploring AI-driven solutions is a plus.
- Preferred: Excellent organizational, communication, and problem-solving skills.
Education
- Bachelorβs degree in Engineering, Life Sciences, Business or a related technical field; Vocational Technical School or Military training also highly considered.