Technical Services Engineer - OSD Equipment

• Serve as a hands-on equipment SME for assigned OSD manufacturing systems and provide day-to-day technical support to Manufacturing for reliable and compliant equipment operation.
• Respond to equipment issues during operation, troubleshoot failures and recurring alarms, perform structured root-cause analysis, and coordinate timely restoration of equipment to service.
• Develop, maintain, 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 work instructions and CMMS job plans, including task frequency, required parts/tools, safety precautions, acceptance criteria, and documentation requirements.
• Support minor equipment repairs, adjustments, replacements, and reliability improvements; provide technical input to change controls when modifications affect qualified equipment.
• Coordinate OEM and specialty-service support when needed and develop sufficient in-house knowledge for routine troubleshooting, maintenance, and recovery.

Calibration, Maintenance and Reliability

• 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 equipment instruments, sensors, motors/VFDs, interlocks, and electrical interfaces with Calibration, Automation/CSV, Facilities, OEMs, or qualified service providers as applicable.
• Perform failure analysis for recurring equipment issues and implement practical corrective actions to improve equipment uptime and reliability.
• Establish and maintain critical spare-parts and consumables strategies, including vendor part numbers, GMP criticality, stocking recommendations, obsolescence risk, and replacement planning.
• Use equipment history, work-order trends, vendor recommendations, and risk/criticality assessments to identify recurring issues and improve preventive maintenance and equipment reliability.

Calibration and GMP Equipment Control

• Support the site Calibration & Maintenance program for assigned OSD equipment, including equipment/instrument master data, critical instrument lists, calibration frequencies, tolerances, ownership, and status.
• Coordinate calibration and performance-check activities for critical manufacturing equipment instruments with calibration service providers, Automation/CSV, CQV, and Quality.
• Review calibration and performance-check records as assigned and support investigation and equipment impact assessment for out-of-tolerance or failed results.
• Maintain equipment-specific calibration instructions, maintenance records, performance-check documentation, and associated GMP equipment records as required.
• Ensure maintenance and calibration work is properly documented and equipment is returned to a safe, controlled, and qualified state before release back to Manufacturing.

Equipment Lifecycle and Documentation Support

• Support equipment handover and post-start-up stabilization as needed, with emphasis on maintainability, spare parts, PM requirements, calibration readiness, and vendor documentation.
• Review vendor O&M manuals, BOMs, maintenance recommendations, drawings, lubrication requirements, instrument lists, and service recommendations and translate them into site maintenance and calibration practices.
• Provide equipment support for manufacturing campaigns, new product introduction, technology transfer, and capacity changes when equipment setup, reliability, maintenance, or calibration support is required.
• Maintain accurate equipment records, including PM plans, calibration records, work orders, spare-parts information, drawings, manuals, and vendor service reports.

GMP, Safety, and Cross-Functional Support

• Execute assigned work in accordance with cGMP requirements, site procedures, EHS requirements, lockout/tagout expectations, and applicable engineering and maintenance standards.
• Support deviation investigations, CAPA, change control, risk assessments, audit/inspection responses, and technical impact assessments related to assigned manufacturing equipment.
• Work closely 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 and provide technical coaching as appropriate.
• Participate in continuous-improvement initiatives that improve equipment availability, maintainability, compliance, throughput, and total cost of ownership., This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

• Bachelor’s degree in Mechanical Engineering or a related technical discipline with 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/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 maintenance of equipment in a qualified/controlled state.
• Ability to interpret mechanical drawings, P&IDs, equipment manuals, equipment layouts, parts lists, vendor documentation, and technical specifications; familiarity with basic instrumentation/electrical interfaces is beneficial.
• 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., * Experience with OSD manufacturing and packaging equipment such as granulation, blending/bin handling, roller compaction, milling/sieving, tablet compression, encapsulation, coating, and packaging systems.
• Experience with high-containment OEB3/OEB4 equipment, isolators/containment interfaces, vacuum transfer, and contained material-handling systems.
• Experience developing or optimizing PM 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/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 is desirable.
• Prior experience supporting GMP audits or inspections involving equipment maintenance, calibration, or equipment records is desirable.