Sr. Engineer 35492

Inteldot; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Inteldot, based in Puerto Rico, seeks an Administrative Shift engineer to lead process optimization and troubleshoot operational issues in manufacturing, pilot plant, or capital projects. You will apply advanced engineering principles to design and implement major system modifications and projects.

Responsibilities include owning CMMS work orders, improving equipment reliability, collaborating with engineering, developing performance metrics, and ensuring EH&S compliance across the organization.

Qualifications

• Pharmaceutical/biotech process knowledge required.
• Validation processes familiarity.
• GLP/GMP experience.
• Documentation in regulated environment.
• Ability to operate specialized lab equipment and computers.
• Able to apply engineering science to production.

Responsibilities

• Own CMMS work orders: approval, closure, PM strategy, spare parts definition/updates.
• Collaborate with Engineering for best maintenance strategy on manufacturing equipment.
• Improve system reliability: availability, downtime reduction, maintenance optimization.
• Develop equipment performance metrics (availability, downtime, etc.).
• Lead equipment improvement projects.
• Be SME for systems regarding design, maintenance, compliance operations.
• Support deviation process; define and own CAPAs for equipment within area of expertise.
• Drive EH&S compliance within the organization.

Skills

Process optimization

Troubleshooting

Data interpretation

CAPA management

Education

Doctorate

Masters + 2 years experience

Bachelor’s in engineering

Tools

CMMS

Job description

Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Administrative Shift

Job Description

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Requirements & Qualifications

• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope

Responsibilities

• Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
• Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.
• 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 Drives Environmental, Health and Safety compliance within the organization

Education

• Doctorate OR Masters + 2 years of Engineering experience OR Bachelor’s in engineering + 4 years of Engineering experience.