Responsibilities:
Provide support for Parenteral Operations by performing environmental monitoring of the classified manufacturing areas and by performing utility sampling and analysis within the manufacturing site. Assist QC- Microbiology management with training. Provide support in the manufacturing areas during routine environmental monitoring and utility sampling.
Key Objectives/Deliverables:
• Adhere to and promote compliance with all cGMP procedures, Quality Systems, Good Documentation Practices, and Good Laboratory Practices.
• Provide support for Parenteral Operations activities by performing environmental monitoring of classified manufacturing areas.
• Provide support for manufacturing and laboratory activities by performing utility sampling and analysis.
• Provide support with routine lab maintenance and lab inventory management.
• Assist with technical training and mentoring of QC-Microbiology Technicians through formal process/program.
• Open to flexible work environment.
• Participate in department/company continuous improvement projects and initiatives.
• Assist with authoring Standard Operating Procedures and Work Instruction documentation.
• Adhere to and promote compliance of all safety standards.
Basic Requirements:
• Education- Bachelor's degree in Microbiology or related field; Associates degree or High School Diploma or equivalent.
• Experience- 2+ years demonstrated relevant experience in performing Environmental Monitoring in a GMP Pharmaceutical Manufacturing facility, preferably associated with aseptic production. The number of years of experience can vary based on educational qualifications.
o Demonstrated ability in performing environmental monitoring techniques including, but not limited to viable surface monitoring, viable and non-viable air monitoring, compressed air monitoring, and water and clean steam collection and analysis.
Additional Skills/Preferences:
• Experience with cGMP requirements and regulatory compliance associated with a cGMP Manufacturing facility.
• Strong interpersonal skills and ability to train/mentor QC Environmental Monitoring Technicians.
• Strong oral and written communication skills for communicating to colleagues, management, and other departments.
• Ability to work in a lab environment including wearing appropriate PPE and other safety related equipment or considerations.
• Ability to gown into facility dedicated cleanroom attire, as required to perform job responsibilities.
Travel Requirements:
• Minimal travel required (10%) to other Client sites for training purposes
Physical Requirements:
• Regular (50% - 60%) exertion including standing/walking for extended periods of time, lifting/carrying more than 15 and up to 25 pounds.
• Works with chemicals and wears basic personal protective equipment (PPE) or restrictive PPE as defined by the procedures.
• Required Safety Equipment: Safety glasses, gowning, hearing protection, and safety shoes required per local area requirements.
• At times low physical effort includes sitting and operating computers or other small equipment.
Other Information:
• Position is a day shift role, but requires flexibility to adjust schedule as needed to support the qualification and ongoing running of the area (24/7 operation)
• Ability to work 8 hour days – Monday through Friday
• Ability to work overtime as required.
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
