TALENT PIPELINE - Clean Room Analyst - Microbiological Environmental Monitoring

Cambrex is a leading global contract development and manufacturing organization (CDMO) providing drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a team of more than 2,000 professionals, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

About the role

Cambrex is building a talent pipeline for future Clean Room Analyst – Microbiological Environmental Monitoring positions at our Massachusetts locations in Agawam and Marlborough. This role involves environmental monitoring and cleanroom qualifications within controlled environments, with travel to regional client sites to ensure compliance with safety and regulatory requirements for medical devices, pharmaceuticals, and other patient products.

Responsibilities

• Perform environmental monitoring and cleanroom qualifications in controlled environments.
• Travel to client sites to provide expertise on equipment, procedures, policies, and regulations.
• Measure total air particulate, temperature, humidity, and differential pressure.
• Collect viable air and surface samples, as well as purified water samples for testing.
• Incubate media plates and enumerate microbial growth; submit growth for microbial identification per procedure.
• Maintain and prepare equipment in a GMP environment; complete documentation per GDP.
• Transport equipment and media to client sites within the New England region using company-provided vehicles.
• Familiarize with client cleanroom layouts, sampling plans, and contamination control programs.
• Perform sterile gowning and stage equipment/media into client cleanrooms for testing.
• Additional duties as assigned.

Experienced Analysts will also:

• Perform compressed gas testing and HEPA filter testing.
• Write risk assessments, sampling plans, investigations, protocols, reports, SOPs, and other technical documents.
• Design and build electronic workflows.
• Peer review data and assist with training.
• Cross-train to support other business functions, including Validations, Metrology, Microbiology, Quality Assurance, Sales Support, and Leadership.

Requirements

• Ability to read, analyze, and follow SOPs, technical procedures, and governmental regulations.
• Mathematical skills to analyze scientific and test data, including basic statistical analysis.
• Ability to present information effectively to internal and external audiences.
• Strong report-writing and business correspondence skills.
• Excellent interpersonal and communication skills (verbal, written, and active listening).
• Valid driver’s license with a good driving record.

Qualifications

Entry Level

• Associate’s degree in Microbiology or related field with a minimum of 12 months of cleanroom experience or High School Diploma with 24 months of cleanroom experience.
• Sterile gowning experience preferred.

Expert Level

• Bachelor’s degree or higher in Microbiology or related field.
• Minimum of 12 months of sterile gowning experience.
• Minimum of 12 months of environmental monitoring sampling and testing experience.
• CETA or NEBB training/certification preferred.

Travel

This role requires frequent travel to client sites, primarily within southern New England, using company-provided vans. Approximately 10% of assignments are multi-day, requiring overnight stays.

Physical Demands

• Frequent standing, walking, and sitting; occasional climbing or balancing.
• Regular use of hands to handle or feel objects/tools; reaching with hands and arms.
• Ability to talk and hear; specific vision requirements include close, distance, and peripheral vision.
• Ability to lift and/or move up to 10 pounds regularly, up to 25 pounds frequently, and up to 50 pounds occasionally.

Work Environment

• Occasional exposure to moving mechanical parts, high places, and vibration.
• Noise levels are usually quiet.
• Access to lab, manufacturing, or clinical areas may be required.
• Use of personal protective equipment (PPE) such as safety eyewear, respirators, lab coats, and gloves is mandatory.