Sr. Engineer 35409

Inteldot; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Inteldot is offering an Administrative Shift position in Puerto Rico focused on process optimization and troubleshooting in manufacturing. The ideal candidate will provide and direct process strategies, apply engineering principles to system modifications, and lead equipment improvement projects.

The role requires advanced qualifications in engineering, with experience in pharmaceutical or biotech processes being essential. Join us to enhance system reliability and compliance within a regulated environment.

Responsibilities

• Manufacturing Equipment ownership at CMMS system.
• Collaborate with Engineering Staff to ensure maintenance strategy.
• Responsible for enhancing system reliability.
• Develop equipment performance metrics.
• Lead the implementation of equipment improvements project.
• Support equipment troubleshooting.
• Drive Environmental, Health and Safety compliance.

Skills

Working knowledge of pharmaceutical/biotech processes

Familiarity with validation processes

Familiarity with documentation in a highly regulated environment

Ability to operate specialized laboratory equipment

Ability to interpret and apply GLPs and GMPs

Ability to apply engineering science to production

Able to develop solutions to routine technical problems

Education

Doctorate degree or Master degree and 3 years of Engineering experience

Bachelor degree in Engineering and 5 years of Engineering experience

Job description

Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, United States, 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 project.
• 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 with equipment within area of expertise. Drives Environmental, Health and Safety compliance within the organization.

Education:

• Doctorate degree or Master degree and 3 years of Engineering experience or Bachelor degree in Engineering and 5 years of Engineering experience