This position is no longer open for applications

Environmental Monitoring Formulations Scientist

Employee Responsibilities:

• Support pilot plant operations for the GMP manufacturing of sterile, biologic, and vaccine clinical supplies. Interfaces with a large network including multiple research, commercialization, commercial supply, and other pilot plants teams
• Understand and execute classified facility and aseptic processing area EM Program requirements
• Perform compliance improvement projects and manage change that supports improvement to the EM program and area sterility assurance
• Investigate EM events (write and review investigations)
• Trend and evaluate data (e.g. Classified facility Qualification, Requalification, Performance Qualification, Microbial Isolates review, Investigation trending, etc.)
• Provide Subject Matter Expertise in sampling techniques and aseptic techniques, including training co-workers
• Manage/maintain department EM metrics
• Create and/or maintain EM schedules, sampling locations, and area sampling maps
• Use LIMS to plan EM sampling tasks
• SOP creation, update, review, and/or approval
• Manage gown qualification program
• Change control for EM
• Routine EM tasks such as troubleshooting tester questions, particulate monitoring data review, etc.
• Collaborate with Quality partners
• Airflow Visualization Study protocol creation and completion
• Utilities EM support, including gas and water sampling data trending
• Maintain gown qualification status for access to aseptic manufacturing area
• Classified facility HEPA filtered air velocity checks
• Support aseptic processing area process simulations
• Quality Risk Management. Participate in quality risk assessments
• Support training, GMP, and safety initiatives

The Ideal Candidate would possess:

• Previous experience in an EM role supporting sterile, biologic, or vaccine operations, and/or process development activities
• Previous experience and knowledge of aseptic unit operations, including aseptic gown qualification
• Previous experience and extensive knowledge of cGMPs
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Minimum Qualifications:

• Bachelor’s/Master’s degree in microbiology, engineering, biomedical engineering, chemistry, biology, or related field with 1-2 years of relevant experience
• Authorization to work in the United States indefinitely without restriction or sponsorship

What we offer:

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Position is full-time, Monday through Friday, 8 a.m. to 5 p.m., with the ability to flex hours as needed to support manufacturing. Position will support manufacturing operations, therefore weekend and holiday work may be necessary. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

Eurofins Lancaster Laboratories Professional Scientific Services^® (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.

We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.

To learn more about Eurofins Lancaster Laboratories, please explore our website www.eurofinsus.com.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.