We are seeking an experienced Equipment Engineer to support the design, installation, commissioning, qualification, maintenance, and optimization of manufacturing equipment in a regulated production environment. The ideal candidate will have hands‑on experience with pharmaceutical process equipment, equipment troubleshooting, engineering documentation, and equipment lifecycle management. This role will ensure equipment operates safely, reliably, and in compliance with cGMP and regulatory requirements.
Key Responsibilities:
- Provide engineering support for manufacturing and process equipment across pharmaceutical or biotech operations.
- Lead equipment installation, commissioning, startup, qualification, and performance improvement activities.
- Support equipment troubleshooting, failure investigations, and root cause analysis.
- Develop and review equipment specifications, engineering drawings, P&IDs, equipment layouts, and technical documentation.
- Coordinate with OEMs, vendors, contractors, and internal engineering teams for equipment installation, modifications, and upgrades.
- Execute and support FAT, SAT, IQ, OQ, and PQ activities.
- Support preventive and predictive maintenance strategies to improve equipment reliability and uptime.
- Identify opportunities to improve equipment performance, operational efficiency, and maintenance effectiveness.
- Manage equipment‑related deviations, change controls, CAPAs, and engineering modifications.
- Support equipment lifecycle management, including upgrades, replacements, and obsolescence planning.
- Collaborate with Manufacturing, Maintenance, Quality, Validation, and Process Engineering teams.
- Ensure equipment and engineering activities comply with cGMP, EHS, and applicable regulatory requirements.
Required Qualifications:
- Bachelor's degree in Mechanical, Electrical, Chemical, or Industrial Engineering, or a related technical discipline.
- 5–10 years of experience in equipment engineering, manufacturing engineering, or maintenance engineering.
- Hands‑on experience with pharmaceutical, biotech, or industrial manufacturing equipment.
- Knowledge of equipment installation, commissioning, qualification, and validation.
- Experience with equipment troubleshooting, root cause analysis, and reliability improvement.
- Ability to interpret P&IDs, engineering drawings, equipment specifications, and technical documents.
- Experience with FAT, SAT, IQ, OQ, and PQ documentation and execution.
- Understanding of cGMP requirements, change control, deviations, and CAPA processes.
- Strong technical problem‑solving, project coordination, and communication skills.