
Microbiologist II
- Virginia
- Permanent
- Full-time
- Responsible for performing the environmental monitoring of the designated areas and support facilities during and after production.
- Responsible for collecting, testing, interpreting and reporting results for water, steam, air and compressed gases for micro testing.
- Responsible for performing and qualifying disinfectant studies.
- Responsible for validating microbiology test methods.
- Responsible for trending and various assessments/reports as required, e.g. quarterly and yearly reports.
- Responsible for assuring that required media is available and that the necessary qualifications are met, e.g. growth promotion.
- Responsible for conducting microbial identifications, whether by in-house methods or preparing and sending off-site.
- Responsible for lab organizational/operational set-up and qualification.
- Responsible for supporting validation/qualification activities (process/equipment/facility).
- Responsible for developing, transferring and validating microbiology test methods.
- Responsible for creating and maintaining a library of microbial organisms.
- Responsible for preparing samples for shipment to contract labs as applicable.
- Responsible for drafting/amending Standard Operating Procedures (SOP) for the micro lab as needed.
- Responsible for preparing written reports of investigations as needed.
- Responsible for entering/reviewing data generated by other analyst(s) as needed.
- Responsible for supporting production, validation and quality assurance as needed.
- Responsible for completing training requirements and maintaining compliance with assignments.
- Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's), Work Instructions (WI) and Batch Record instructions.
- Responsible for performing additional related duties as assigned.
- Requires Bachelor's of Science degree with a minimum of 3 years relevant progressive experience in a microbiology laboratory with an emphasis on environmental monitoring activities.
- Experience in a manufacturing environment within pharmaceutical, medical device or nutraceutical industries is preferred.
- Understanding of cGMP is strongly preferred.
- Computer proficiency and working knowledge of MS Office products and systems such as EAM, SAP, Oracle, TrackWise and other computer relational databases.
- Self-directed with ability to organize and prioritize work.
- Detail oriented with ability to analyze information, create metrics and articulate the link to business needs/objectives.
- Interact positively and collaborate with co-workers, management and external partners.
- Communicate effectively with strong written and oral communication and technical writing skills.
- Ability to manage multiple priorities and reporting requirements.
- Ability to motivate, influence and lead others with and/or without direct supervisory authority.
- Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
- Seeks out all resources when selecting methods and techniques for obtaining results.
- Acts independently and proactively to recommend and administer methods and procedures for problem resolution.