Are you our match?

We’re looking for Junior and Senior Qualification Specialists to generate, review, execute and report technical protocols. If you’ve got the skills, we’d like to hear from you!

Position: Several positions available

Location: Puerto Rico North Area, Puerto Rico South Area, USA East Coast, USA Central Area

Job Type: Contract 6 to 12 months

Starting Date: November 2024

Job description: The ideal candidate has a minimum of 5 years’ experience working in a biopharmaceutical manufacturing environment. The Qualification Specialist is responsible for the preparation, execution, and review of qualification plans and reports including:

• Qualification Project Plan
• User Requirement Specification (URS) document
• Functional / Requirement Specifications (FS/DS) documents
• Computer and Computerized System Impact Assessment
• Electronic Records and Electronic Signatures (ERES) Documentation generation
• Generation of Installation and Qualification Protocols (IQ/OQ) to support Computer System Validation (CSV) Activities
• Applies advanced and diverse validation principles to the design and implementation of major systems.
• Coordinate the implementation or scheduling of qualification testing with affected departments and personnel.
• IQOQ Protocol Execution Activities
• PLC / HMI Code Review
• Generation of IQOQ Final Report

Required:

• Bachelor’s degree in Mechanical, Chemical, Electrical Engineer or Bachelor of Science in a related field.
• 5 years of experience in manufacturing processes, automation and quality within a biopharmaceutical manufacturing environment.
• Strong analytical and problem-solving skills.
• Deals well with uncertainty and pressure.
• Works well with others, within a team and takes accountability.
• Results driven and self-motivated.
• Strong interpersonal and communication skills (verbal and presentation).
• Organized, with strong computer literacy such as MS Project, Excel, Word etc.
• Fully fluent in English.

Compensation:

Competitive market compensation will be based on experience.

To apply, please send resume to vicky.paz@principiapr.com