Summary:
We are seeking candidates with a strong engineering background and hands-on experience in regulated manufacturing environments, preferably within the medical device industry. Ideal candidates will have direct experience with process validation activities including characterization, OQ, and PQ (non-cleaning), as well as equipment qualification such as URS, FAT, IQ, OQ, PQ, and TMV (non-laboratory equipment). Experience developing and executing validation strategies, flowing design requirements into manufacturing controls, and supporting design transfer activities is essential. Candidates should also be familiar with risk management tools such as pFMEA, possess basic statistical skills (Minitab preferred), and have participated in project-based validation work that demonstrates practical application of these concepts.

Project:  6 new manufacturing lines for a medical devices company in Juncos-PR

Responsibilities:

1. This role is centered on sustaining manufacturing operations through investigation, compliance, and product quality assurance.
2. Investigate manufacturing events, manage deviations or nonconformances, support product disposition decisions, and perform defect or reject trend analysis.
3. Strong candidates will have experience reviewing and approving validation documentation, supporting sustaining manufacturing activities, and ensuring adherence to quality systems and regulatory requirements.
4. The emphasis for this position is on reactive problem-solving, compliance oversight, and maintaining product and process conformance during ongoing production.

Requirements:

• Education: Bachelor´s degree in Engineering (Mechanical, Electrical, Chemical, etc.)
• 2 to 5 years of minimum experience
• Experienced with medical devices products
• Process Validation (PV): characterization, OQ, PQ (non-cleaning)
• Equipment Qualification (CSV): URS, FAT, IQ, OQ, PQ, TMV (non-lab)
• Validation strategies & requirements flow-down (design → manufacturing)
• Risk management documentation (pFMEA)
• Basic statistics (Minitab preferred)
• Design transfer activities
• Design requirements validation & manufacturing controls
• Project-based validation experience

Work Methodology:

• Full time special project assignment
• Full on-site job in Juncos, PR
• 5 months of special project contract
• Shift:  Administrative and wiling to support non-standard shifts based on project needs