Sterile Pharma Validation Engineer (CQV & Equipment)

Katalyst-Healthcares-; Miami (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC in Miami, FL seeks a validation professional to execute validation studies, including performance qualifications and re-qualifications of manufacturing and laboratory equipment and processes.

You will assist with CQV protocol development for cGMP manufacturing, fill-finish operations, and QC laboratories, and author acceptance reports. The role requires strong technical writing and collaboration across Manufacturing, QA, Engineering, and QC teams.

Qualifications

• 3–5 years of experience in a sterile pharmaceutical and FDA-regulated industry.
• Validation experience.
• Sterile manufacturing experience.
• Working knowledge of Microsoft Office applications.
• Knowledge of cGMP requirements, Good Documentation Practices, and validation of manufacturing and laboratory equipment or processes.
• Strong technical writing, communication, organization, and cross-functional collaboration skills.
• Familiarity with equipment and systems such as mix tanks, autoclaves, vial/syringe fillers, HVAC systems, and aseptic processing areas.

Responsibilities

• Execute validation studies, including performance qualifications and re-qualifications of manufacturing and laboratory equipment or processes.
• Assist with writing and executing Commissioning, Qualification, and Validation (CQV) protocols supporting cGMP manufacturing, fill-finish operations, and QC laboratories.
• Author acceptance reports and provide validation activity updates to project teams.
• Support facility and utility expansions, compliance upgrades, process improvements, construction projects, and related initiatives.
• Apply Good Documentation Practices, cGMP requirements, and current industry practices to equipment and systems validation.
• Collaborate with Manufacturing, Quality Assurance, Engineering/Maintenance, and Quality Control teams.
• Review change controls, work orders, document change requests, and vendor-generated validation protocol packages.
• Update applicable SOPs following completion of validation activities.
• Support limited multi-shift operations, training, and testing as needed.

Skills

Validation

Sterile manufacturing

cGMP compliance

Technical writing

Cross-functional collab

Documentation practices

Education

Associate of Science degree in technical/scientific discipline

Bachelor of Science degree desired

Tools

Microsoft Office

Job description

Roles & Responsibilities:

• Execute validation studies, including performance qualifications and re-qualifications of manufacturing and laboratory equipment or processes.
• Assist with writing and executing Commissioning, Qualification, and Validation (CQV) protocols supporting cGMP manufacturing, fill-finish operations, and QC laboratories.
• Author acceptance reports and provide validation activity updates to project teams.
• Support facility and utility expansions, compliance upgrades, process improvements, construction projects, and related initiatives.
• Apply Good Documentation Practices, cGMP requirements, and current industry practices to equipment and systems validation.
• Collaborate with Manufacturing, Quality Assurance, Engineering/Maintenance, and Quality Control teams.
• Review change controls, work orders, document change requests, and vendor-generated validation protocol packages.
• Update applicable SOPs following completion of validation activities.
• Support limited multi-shift operations, training, and testing as needed.
  

Required skills:

• Minimum 3–5 years of experience in a sterile pharmaceutical and FDA-regulated industry.
• Validation experience.
• Sterile manufacturing experience.
• Working knowledge of Microsoft Office applications.
• Knowledge of cGMP requirements, Good Documentation Practices, and validation of manufacturing and laboratory equipment or processes.
• Strong technical writing, communication, organization, and cross-functional collaboration skills.
• Familiarity with equipment and systems such as mix tanks, autoclaves, vial/syringe fillers, HVAC systems, and aseptic processing areas.
  Education
• Associate of Science degree in a technical or scientific discipline required, or three years of related experience in lieu of a degree.
• Bachelor of Science degree desired.