3-5 years in a sterile pharmaceutical and FDA-regulated industry
Experience in validation processes
Background in sterile manufacturing
Proficient in Microsoft Office
Knowledge of cGMP and Good Documentation Practices
Strong technical writing and communication skills
Familiarity with mix tanks, autoclaves, and aseptic processing
Responsibilities
Execute validation studies for manufacturing and laboratory equipment
Assist in writing and executing Commissioning, Qualification, and Validation (CQV) protocols
Author acceptance reports and update project teams on validation activities
Support compliance upgrades and process improvements
Apply cGMP and industry best practices during validation
Collaborate with cross-functional teams including Manufacturing and Quality Assurance
Review change controls and vendor validation protocols
Update Standard Operating Procedures (SOPs) post-validation
Benefits
Health, dental, and vision insurance
401(k) retirement plan
Paid time off and holidays
Professional development opportunities
Flexible working arrangements
Full 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.
