Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Job Description:
Under general supervision, provides support as a technical expert to equipment or systems regarding troubleshooting operations. Actively involved in daily operations to meet schedules or to resolve complex problems. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.
Administrative shift: Monday – Friday 7:30am – 4:30pm.
Requirements and responsibilities:
- Experience in reliability engineering, maintenance strategy, and process improvement.
- Working knowledge of pharmaceutical/biotech processes and ability to interpret and apply GLPs and GMPs.
- Familiarity with validation processes and documentation in a highly regulated environment.
- Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
- Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization
- Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.
- Lead the implementation of equipment improvements projects.
- SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.
- Support equipment troubleshooting within the functional area or in the scope of technical expertise.
- Support deviation process and define, implement and own CAPAs associated to equipment within area of expertise.
Education:
• Bachelor degree in Engineering and two (2) years of Engineering experience