Technical Services Engineer - OSD Equipment

WuXi AppTec•Middletown, DE

6d•Onsite

About The Position

The Technical Services Engineer - OSD Equipment supports day-to-day operation and reliability of Oral Solid Dosage manufacturing equipment at the Middletown drug product facility. The role is embedded in routine manufacturing support and focuses on troubleshooting, preventive and corrective maintenance, calibration coordination, spare-parts management, CMMS execution, and GMP equipment records. The positions are individual-contributor roles with no direct reports and emphasize sustaining existing equipment rather than leading capital-project execution. The Engineer works closely with Manufacturing, Calibration/Maintenance, Automation/CSV, CQV, Quality, EHS, Facilities, equipment vendors, and service providers. The role supports equipment lifecycle documentation, manufacturing campaigns, product introductions, technology transfer, capacity changes, investigations, change controls, and continuous improvement while ensuring equipment is safe, controlled, and qualified before release to Manufacturing.

Requirements

Bachelor's degree in Mechanical Engineering or a related technical discipline and at least 3 years of relevant pharmaceutical or regulated manufacturing-equipment experience; an equivalent combination of education and strong hands-on equipment maintenance/support experience may be considered.
Demonstrated hands-on experience supporting, troubleshooting, maintaining, and repairing industrial or pharmaceutical manufacturing equipment.
Working knowledge of preventive and corrective maintenance, calibration coordination, equipment reliability, spare-parts management, and CMMS/work-order systems.
Understanding of cGMP equipment lifecycle requirements, maintenance documentation, change control, deviation/CAPA processes, and maintaining equipment in a qualified and controlled state.
Ability to interpret mechanical drawings, P&IDs, equipment layouts, parts lists, vendor documentation, manuals, and technical specifications.
Strong structured troubleshooting and root-cause analysis skills, with the ability to communicate clear and practical technical recommendations.
Ability to work effectively with Manufacturing, Engineering Management, CQV, Quality, EHS, Automation/CSV, Facilities, vendors, and contractors in a fast-paced start-up and operational environment.

Nice To Haves

Experience with OSD manufacturing and packaging equipment, including granulation, blending/bin handling, roller compaction, milling/sieving, tablet compression, encapsulation, coating, and packaging systems.
Experience with high-containment OEB3/OEB4 equipment, isolators and containment interfaces, vacuum transfer, and contained material-handling systems.
Experience developing or optimizing preventive-maintenance programs, reliability strategies, equipment criticality assessments, critical-spare strategies, and CMMS master data/job plans.
Experience supporting routine GMP manufacturing operations, equipment maintenance, troubleshooting, calibration, and equipment documentation in a pharmaceutical environment.
Working knowledge of calibration and performance-check programs and critical instrument management for manufacturing equipment.
Experience with SAP or another enterprise CMMS and familiarity with OEM service management, work-order execution, equipment history, and reliability tools.
Prior experience supporting GMP audits or inspections involving equipment maintenance, calibration, or equipment records.
Familiarity with basic instrumentation and electrical interfaces.

Responsibilities

Serve as a hands-on equipment subject matter expert for assigned OSD manufacturing systems and provide day-to-day technical support for reliable, compliant operation.
Troubleshoot equipment failures and recurring alarms, perform structured root-cause analysis, and coordinate restoration of equipment to service.
Develop and improve preventive-maintenance plans and equipment maintenance strategies using vendor manuals, operating history, risk assessments, and production experience.
Create and maintain preventive and corrective maintenance instructions and CMMS job plans, including frequencies, parts and tools, safety precautions, acceptance criteria, and documentation requirements.
Support minor equipment repairs, adjustments, replacements, and reliability improvements; provide technical input to change controls affecting qualified equipment.
Coordinate OEM and specialty-service support and build in-house capability for routine troubleshooting, maintenance, and recovery.
Provide mechanical support for motors, gearboxes, bearings, seals, couplings, belts, chains, pumps, valves, pneumatic and vacuum systems, material-handling equipment, lifts/hoists, guards, and containment interfaces.
Coordinate calibration and technical support for instruments, sensors, motors/VFDs, interlocks, and electrical interfaces with relevant internal teams and qualified external providers.
Analyze recurring equipment failures and implement corrective actions to improve uptime and reliability.
Establish and maintain critical spare-parts and consumables strategies, including part numbers, GMP criticality, stocking recommendations, obsolescence risk, and replacement planning.
Use equipment history, work-order trends, vendor recommendations, and risk assessments to identify recurring issues and improve maintenance and reliability.
Support the site Calibration & Maintenance program, including equipment and instrument master data, critical instrument lists, calibration frequencies, tolerances, ownership, and status.
Coordinate calibration and performance checks for critical manufacturing equipment instruments.
Review calibration and performance-check records as assigned and support investigations and equipment impact assessments for out-of-tolerance or failed results.
Maintain calibration instructions, maintenance records, performance-check documentation, and other required GMP equipment records.
Ensure maintenance and calibration work is documented and equipment is returned to a safe, controlled, and qualified state before release to Manufacturing.
Support equipment handover and post-start-up stabilization, focusing on maintainability, spare parts, preventive maintenance, calibration readiness, and vendor documentation.
Review vendor manuals, bills of materials, maintenance recommendations, drawings, lubrication requirements, instrument lists, and service recommendations and translate them into site practices.
Provide equipment support for manufacturing campaigns, new product introduction, technology transfer, and capacity changes.
Maintain accurate equipment records, including maintenance plans, calibration records, work orders, spare-parts information, drawings, manuals, and vendor service reports.
Perform assigned work in accordance with cGMP, site procedures, EHS requirements, lockout/tagout expectations, and applicable engineering and maintenance standards.
Support deviation investigations, CAPA, change control, risk assessments, audit and inspection responses, and technical impact assessments related to assigned equipment.
Work with Manufacturing to prioritize equipment issues and plan maintenance windows while protecting safety, product quality, schedule, and equipment reliability.
Support creation and revision of maintenance SOPs, technical work instructions, troubleshooting guides, and equipment training materials; provide technical coaching as appropriate.
Participate in continuous-improvement initiatives to improve equipment availability, maintainability, compliance, throughput, and total cost of ownership.