Environmental Monitoring Technicians - I

Our Manufacturing & Supply Division is dedicated to being the most trusted global supplier of biopharmaceuticals. Within our Quality Operations group, every product component is manufactured, processed, tested, packaged, and distributed to meet the highest standards of quality and regulatory compliance. We are seeking an Environmental Monitoring (EM) Analyst to support our aseptic manufacturing operations. This role is responsible for maintaining the environmental and utility monitoring program to ensure a reliable and compliant supply of vaccines and biopharmaceutical products. The ideal candidate will have hands-on experience in microbiological laboratory operations or aseptic manufacturing and be comfortable working in a GMP-regulated environment on an evening shift schedule.

Responsibilities

• Execute environmental monitoring of classified areas, including active air, surface, and non-viable air sampling.
• Collect and test qualified utility systems such as Clean Steam, Water for Injection (WFI), and compressed gases.
• Perform routine personnel monitoring and compile sample accountability reports on a weekly and monthly basis.
• Record, review, and approve data entries in LIMS and ensure documentation accuracy and compliance.
• Compile and evaluate environmental data to identify and address adverse trends.
• Author and summarize Requalification, Performance Qualification (PQ), and Special Study protocols.
• Support performance qualification activities and participate in investigations and GMP documentation updates.
• Conduct TOC analysis, conductivity testing, and gas testing as needed.
• Manage calibration, maintenance, and documentation control of EM equipment and logbooks.
• Provide summaries of test results and support audits and annual reviews.

Education

• Minimum: Associate’s degree, preferably in a scientific field.
• Preferred: Bachelor’s degree in Biological Sciences.

Experience

• Minimum 1 year of post-degree experience in Environmental Monitoring, Aseptic Manufacturing, or Microbiological Laboratory Operations.
• Strong oral and written communication skills, including the ability to present ideas clearly and collaborate across teams.
• High attention to detail, flexibility, and awareness of production and quality control considerations.
• Basic understanding of GMPs and regulatory requirements in vaccine or sterile pharmaceutical operations.
• Ability to perform physical tasks, including sitting, standing, repetitive motions, and lifting up to 50 lbs.

Preferred Skills:

• EM sampling experience in a GMP pharmaceutical setting (not EPA).
• Experience with Quality Control, Quality Assurance, or cGMP processes.
• Prior experience using GLIMS or equivalent laboratory information systems.

Additional Information

• Shift: Sunday–Wednesday, 4:00 PM – 2:30 AM EST (4x10 schedule).
• Training Period: 8–12 weeks; flexibility required. Training may occur Monday–Friday, during either day (8 AM–5 PM) or evening (4 PM–10 PM) shifts.
• Pre-Employment Requirements: Candidate must pass a varicella titer and BCG screening prior to start.
• Work Environment: Strict adherence to Merck’s dress and safety policies is required — business casual attire only (no athletic wear, makeup, jewelry, nail polish, or long nails).
• Note: Candidates with Master’s or Ph.D. degrees will be considered overqualified.