Process Engineer II (Relocation Assistance)

Process & Equipment Improvement

• Owns the technical process for assigned IDAP equipment; defines and maintains centerlines, critical process parameters, material fit for use, and operating procedures to ensure a capable, repeatable process.
• Drives continuous improvement for assigned IDAP processes, including changeover reduction, yield and OEE improvements, maintenance reliability, and waste reduction.
• Tracks equipment data, capabilities, utilization, efficiencies, and obsolescence for assigned assets; manages asset lifecycle and develops user requirements for new asset procurement.
• Provides engineering and project management for assigned projects, including developing project justification, tracking milestones, and informing capital planning.

Validation & Technical Support

• Leads validation activities for assigned processes, defining success criteria, confirming process capability, and maintaining validated state through change.
• Authors and reviews URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned processes.
• Troubleshoots assigned IDAP processes, diagnosing and resolving equipment and process deviations, including on-call support as required.
• Works directly with equipment and material suppliers on assigned processes to resolve technical issues.

Quality Systems & Compliance

• Identifies, develops, and manages implementation of change controls for assigned processes to improve performance and address root causes.
• Performs and maintains risk management activities for assigned new and existing processes and equipment.
• Initiates deviations and independently leads technical investigations and impact assessments for assigned processes.
• Authors and reviews controlled documents including SOPs, Batch Records, and Rework procedures for assigned processes.
• Supports regulatory inspections as the process owner for assigned IDAP equipment.

Training & Development

• Identifies technical training requirements for Operations, Engineering, and Maintenance for assigned processes, and develops and delivers training materials.

Minimum Qualifications

• Prior experience or exposure in a GMP or regulated manufacturing environment, with a demonstrated ability to follow controlled procedures and quality standards.
• Prior training or hands-on experience in one or more IDAP-relevant technologies, such as mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, computerized systems, vision systems, aseptic/controlled environments, packaging equipment, process or cleaning validation, or change control.
• Baseline proficiency in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.
• Ability to work with limited supervision, exercising independent judgment on assigned processes.

Preferred Qualifications

• Bachelor's degree in Engineering or related science, and 2+ years of experience in a GMP or regulated pharmaceutical manufacturing environment.
• Experience with project management and process-improvement methodologies (Six Sigma, Lean).
• Expertise in at least one of the following disciplines: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.