Facilities Project Engineer III

MedChem Engineering Services LLC is a recruiting and staffing company dedicated to helps companies recruit and manage contingent workers by providing the best talent in the industry for every client needs. MedChem operates in Puerto Rico. For more information, please visit our website: www.medchemengineeringservices.com

Job Description:

Responsibilities and Scope Participate actively in the Validation Life Cycle for facilities and utilities projects in regulated environments. Develop and execute validation documentation including Validation Plans, URS, FRS, SDS, traceability matrices, and IQ/OQ/PQ protocols. Prepare and review validation protocols, reports, and supporting technical documentation. Support CAPEX projects related to facilities systems such as HVAC, compressed air, and utilities. Perform risk assessments and ensure proper traceability throughout validation activities. Analyze test results and determine acceptability based on predefined criteria. Develop statistically based sampling plans for validation and inspection activities. Investigate and document non-conformances, deviations, and CAPA activities. Provide troubleshooting support for automated and computerized systems during validation execution. Recommend and implement process and quality improvements identified during validation activities. Support installation, commissioning, and qualification of equipment and systems. Coordinate with vendors, contractors, and internal teams for project execution and validation readiness. Oversee validation contractors and ensure compliance with project timelines and deliverables. Generate metrics and reports to monitor validation system performance (e.g., trending, Pareto analysis). Prepare documentation for Quality Management Reviews and Operational Reviews. Collaborate with cross-functional teams including Engineering, Quality, Regulatory, Manufacturing, and EHS. Ensure compliance with regulatory requirements such as FDA, ISO, OSHA, EPA, and GMP standards. Participate in internal and external audits (FDA, Notified Bodies, Corporate). Support regulatory submissions and technical documentation as required.

Knowledge, Skills, and Abilities Strong knowledge of Computer Systems Validation (CSV) and GAMP 5 guidelines. Experience with validation processes including IQ/OQ/PQ, FAT/SAT, and lifecycle documentation. Knowledge of FDA, GMP, ISO, OSHA, and EPA regulations. Experience in facilities systems validation (HVAC/HEPA filtration, utilities, compressed air). Strong analytical and statistical skills for data analysis and validation reporting. Solid project management and organizational skills. Knowledge of Lean/Six Sigma methodologies is preferred. Ability to develop technical documentation such as SOPs, Change Controls, validation reports, and investigation reports. Strong troubleshooting and problem-solving capabilities. Excellent communication and cross-functional collaboration skills. Ability to lead complex validation and engineering projects.

Education and Experience Bachelor’s Degree in Engineering or related field is required. Minimum of 6+ years of experience in pharmaceutical, biotechnology, or medical device industries. Proven experience in facilities validation and protocol writing is required.

Other Requirements: On-site position in Añasco, Puerto Rico (Monday–Friday). Availability for weekends and overtime as needed for testing activities. Experience supporting CAPEX projects is highly preferred.

**CANDIDATE MUST LIVE IN PUERTO RICO**

No relocation nor travel expenses.

Job Types: Full-time, Contract

Pay: $45.00 - $57.00 per hour

Work Location: In person