Equipment Mechanical Engineer

2 weeks ago

Singapore No deviation Pte Ltd Full time

We are looking for **Equipment Mechanical Engineer** to support the **operation, maintenance, and reliability** of **biotechnology process equipment and systems**. This role requires hands-on troubleshooting, technical assessments, and continuous improvement of equipment reliability within a **GMP-regulated pharmaceutical environment**.

**Key Responsibilities**
- Ensure the **operation and reliability** of **biotechnology process equipment**.
- Troubleshoot **equipment failures and malfunctions**, providing **technical assessments and corrective actions** during normal and after-hours when required.
- Develop, implement, and optimize **preventive maintenance strategies**, including **job plan creation and datasheet development** in **systems**.
- Investigate **deviations**, develop **corrective and preventive actions (CAPA)**, and implement **change controls** in a **timely** and **compliant** manner.
- Conduct **process equipment periodic reviews**, including **data integrity and security assessments**.
- Collect, analyze, and present data for **operational issues and engineering projects** of varying complexity.
- Lead or support **engineering projects** within **schedule, budget, and quality** constraints.
- Manage **commissioning and qualification** activities such as **FAT, SAT, automation checkouts, IQ, OQ, PQ**, and ensure **asset, preventive maintenance, and spare parts creation** for new process equipment.
- Participate in **system walk-downs**, ensure **closure of punch list items**, and facilitate smooth transition of systems from project to operations.

**Service Expectations**
- Provide **timely support** for **client inquiries** during **normal working hours and after-hours**, if required.
- Ensure **qualified and experienced personnel** are placed on-site for durations based on client needs. Any change in assigned personnel will require client approval.
- Participate in **periodic service level performance reviews** based on agreed **KPIs** with the client.
- Proactively recommend **continuous improvement initiatives**, including **cost reduction and technical enhancements** to optimize equipment performance.

**Requirements**:

- ** Degree/Diploma in Mechanical Engineering** or a related field.
- ** 3-5 years of experience** in **process equipment maintenance, troubleshooting, and reliability** within a **biotechnology, pharmaceutical, or GMP-regulated environment**.
- Strong expertise in **biotech process equipment and single-use systems**.
- Hands-on knowledge of **equipment qualification protocols** (FAT, SAT, IQ, OQ, PQ).
- Understanding of **Operational Excellence (Lean, Six Sigma)** principles.
- Strong **problem-solving skills** and ability to work independently or within a team.
- Excellent communication skills for effective collaboration with **cross-functional teams and stakeholders**.

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