STD Catalent-Transition-85

Key Responsibilities

• Execute advanced troubleshooting and diagnostics for building automation, process control, and analytical instrumentation systems.
• Carry out precision calibrations across diverse instrument portfolios, including flow meters, pressure transmitters, temperature sensors, and analytical equipment.
• Optimize control loop performance to achieve superior environmental control and energy efficiency outcomes.
• Perform multi-point calibrations on temperature transmitters, pressure sensors, flow devices, pH meters, conductivity analyzers, and gas chromatography systems using NIST-traceable standards.
• Execute linearity checks, span adjustments, and zero calibrations on analytical balances, spectrophotometers, particle counters, and environmental monitoring equipment.
• Utilize dead weight testers, dry block calibrators, and multifunction process calibrators to achieve required measurement uncertainties.
• Work with and around building management systems (BMS) and computerized maintenance monitoring system (CMMS) to perform daily tasks and manage current good manufacturing procedure (CGMP) data.
• Execute calibrations on Water for Injection (WFI) conductivity and TOC analyzers, Clean Steam quality monitors, and compressed gas purity analyzers.
• Calibrate HVAC differential pressure transmitters, environmental chamber instrumentation, and filling line equipment including weight checks and volume verification systems.
• Generate calibration certificates documenting as-found/as-left conditions and measurement uncertainties.
• Maintain calibration databases and ensure IQ/OQ/PQ compliance.
• Develop calibration procedures and establish intervals based on drift analysis.
• Program risk-based calibration strategies considering instrument criticality and regulatory requirements.
• Analyze calibration data to optimize intervals and recommend equipment upgrades.
• Cook up schedules to minimize process disruption while meeting compliance timelines.
• Manage vendor relationships for specialized calibration services.
• Deliver technical training on calibration techniques and troubleshooting methodologies.
• Deliver technical training on calibration techniques and troubleshooting methodologies.

Documentation and Compliance

• Generate calibration certificates documenting as-found/as-left conditions and measurement uncertainties.
• Maintain calibration databases and ensure IQ/OQ/PQ compliance.
• Execute activities per FDA, EMA, and ICH guidelines with 21 CFR Part 11 compliance.

Technical Systems Management

• Work with and around building management systems (BMS) and computerized maintenance monitoring system (CMMS) to perform daily tasks and manage current good manufacturing procedure (CGMP) data.

Preferred Qualifications

• Education and Experience: Bachelor's degree in Engineering, Instrumentation, or related technical discipline. Minimum five years of hands-on experience with instrumentation, controls, and calibration in pharmaceutical or biotechnology environments.
• Technical Expertise: Comprehensive knowledge of calibration standards, procedures, and documentation requirements for analytical and process instruments. Proficiency with calibration software and diagnostic tools including Fluke systems and CMMS Maximo platforms. Advanced understanding of process control theory, PID loop tuning, and control optimization strategies. Industry Knowledge: Experience with laboratory and analytical instrumentation calibration and maintenance. Working knowledge of 21 CFR Part 11 compliance requirements. Familiarity with Building Management Systems including Siemens, DeltaV, Honeywell, and Allen Bradley platforms.
• Certifications and Standards: Relevant professional certifications in instrumentation, calibration, or controls (ISA, NIST) strongly preferred. Demonstrated application of GMP and GLP principles in instrumentation and calibration activities.
• Professional Skills: Proven customer service experience with client interaction capabilities. Exceptional interpersonal communication skills, both oral and written. Ability to work independently with minimal supervision while maintaining focus and productivity.

Required Qualifications

• Technical Competencies: Demonstrated ability to interpret technical drawings, P&IDs, and instrument specifications. Strong analytical and problem-solving capabilities for complex technical challenges. Proficiency in standard business applications including MS Office Suite, Outlook, and CMMS systems.

Physical Requirements

• Valid driver's license required.
• Ability to work in clean room manufacturing environments, including compliance with gowning and respirator protocols.
• Capability to perform overhead work and operate at elevated heights.
• Physical capacity to operate electric hand tools, work from ladders, transport equipment, and lift heavy materials.

Environmental Adaptability

• Flexibility to work in diverse environmental conditions, including outdoor assignments in various weather conditions.
• Availability for on-call responsibilities as operational needs require.