Senior Program Manager
Red 6
Process Engineer
CAI
full-time
Posted on:
Location Type: Office
Location: Providence • Rhode Island • 🇺🇸 United States
Visit company websiteSalary
💰 $36 - $50 per hour
Job Level
Mid-LevelSenior
About the role
- Design, operate, install, troubleshoot, commission, and qualify cGMP manufacturing process activities within isolators or biosafety cabinets
- Support sterile operations including vial, prefilled syringe, and cartridge filling lines
- Contribute to pilot and commercial scale bioreactors, centrifugation, chromatography skids, ultrafiltration/diafiltration, depth filtration, and lyophilization/freeze drying processes
- Work with automated visual inspection systems, automated formulation systems, autoclaves, and CIP/SIP systems
- Assist in developing validation/verification master plans, commissioning plans, and qualification protocols
- Perform formal risk assessments (e.g., FMEA) and identify critical attributes and process parameters
- Develop and maintain project plans, schedules, and issue tracking for client projects
- Ensure compliance with regulatory requirements, industry standards, and company quality expectations
Requirements
- BS or MS in a relevant engineering or science field, or equivalent experience
- Three (3) or more years of experience in aseptic process engineering or validation in biotech or pharmaceutical industries
- Excellent oral and written communication skills in English
- Team-oriented, customer-service focused, and able to collaborate effectively with cross-functional teams
- Ability to travel domestically and internationally as required
- Ability to work (paid) overtime as needed
- Eligible to work in the U.S. without sponsorship now or in the future
- Experience with commissioning and qualification projects in regulated industries (preferred)
- Background in developing user requirements, risk assessments, and traceability matrices (preferred)
- Proficiency in project management including planning, estimating, scheduling, and issue resolution (preferred)
- Familiarity with regulatory and industry standards for aseptic processes and validation (preferred)
Benefits
- Comprehensive Health Insurance coverage
- 24 days of Paid Time Off
- ESOP/401K - 15% Company Contribution (US Only)
- Company paid Life Insurance
- Company paid Long Term Disability
- Retirement contribution
- Generous PTO
- Professional education support
- Competitive compensation
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
cGMP manufacturingaseptic process engineeringvalidationcommissioningrisk assessmentsproject managementbioreactorschromatographylyophilizationdepth filtration
Soft skills
communication skillsteam-orientedcustomer-service focusedcollaborationissue resolution
