Inteldot has over 14 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.

We are currently seeking a Laboratory Equipment Specialist with experience in the validation of Glassware Washers or similar equipment to be used in a GxP process.

Key Responsibilities:

Develop all validation deliverables not limited to the following: Roles Assignment Log, Validation Plan, User Requirements, Risk Assessment, Configuration Specifications, Part 11 Assessment, URS, IOQ, PQ, Validation Summary Report and other) for the validation of Equipment.

Support during Vendor Start up and vendor IOQ Execution.

Support the generation of operational and administration Procedures.

Experience incorporating equipment in PM, CAL & Spare Parts Program.

Experience preparing project status report and redlines of drawings.

Requirements:

Bachelor’s degree in Engineering, Life Sciences, or a related field.

3+ years of relevant experience working with Laboratory Glassware Washer (Miele Model PWL 8615 is a plus)

Strong understanding of laboratory equipment and processes.

Hands-on experience with isolator manufacturers such as SKAN, Getinge, or comparable systems is highly desirable.

Solid knowledge of regulatory guidelines.

Proven ability to work collaboratively across cross-functional teams.

Excellent problem-solving skills.

Good technical skills, able to learn the new technology and good communication and organization skills.

Project Details:

Duration: 3 months (with potential extension)