Cleaning Validation Specialist (Sterile Bio-Pharmaceutical Environment)

Job Title: Cleaning Validation Specialist

Location: Juncos, Puerto Rico (Open to Puerto Rico residents only)

Positions Available: 2

Duration: Approximately six (6) months

About the Role

Our client, a leading biopharmaceutical organization, is seeking two Cleaning Validation Specialists to support a high-priority cleaning validation initiative in Juncos, PR. The role involves working with multiple equipment types across active production lines, supporting the development and execution of validation protocols under strict timelines.

Summary

This is a time-sensitive opportunity to contribute to innovative pharmaceutical products in a high-performance environment. Ideal candidates will have hands-on experience generating cleaning validation protocols in sterile manufacturing settings, along with the agility to work under real-world operational constraints. Strong documentation and technical writing skills are essential for success in this role.

Key Responsibilities

Lead and support cleaning validation efforts for the following equipment: Filling lines, Ultrasonic washers, and Parts washers
Develop and execute key documentation within a six-month window:
Validation Plan (VP)
Cleaning Validation Protocols
Final Validation Reports
Coordinate with Manufacturing and Quality teams to access production equipment during limited operational windows, as lines are running at full capacity.
Ensure compliance with applicable cGMP, FDA, and internal quality standards.
Collaborate cross-functionally to ensure alignment on strategy, timing, and execution of validation deliverables.
Assist in addressing deviations, risk assessments, and CAPAs related to cleaning activities.

Qualifications

Bachelor's degree in Chemistry, Engineering, Microbiology, or a related scientific field
Minimum 2–3 years of experience in cleaning validation within GMP-regulated pharmaceutical or biotechnology environments
Demonstrated experience working in sterile/aseptic manufacturing environments
Proven ability to author protocols and technical reports independently
Strong understanding of validation principles, technical writing, and regulatory compliance
Ability to work under tight timelines and limited access windows to equipment
Bilingual (English/Spanish) preferred

To apply, please submit your updated resume through the job description link. We look forward to connecting with qualified candidates ready to make an impact.