Microbiologist II

Microbiologist II Location: Monroe, North Carolina Employment Type: Full-Time | Direct Hire Advance Your Career in Microbiology & Product Quality We are seeking an experienced Microbiologist II to join a quality-focused team in a highly regulated manufacturing environment. This position offers the opportunity to take an active role in microbiological testing, sterilization validation, environmental monitoring, contamination control, and laboratory quality initiatives that directly support product safety and regulatory compliance. This is an excellent opportunity for a microbiologist who enjoys hands‑on laboratory work but is also ready to take greater ownership of validation projects, investigations, technical documentation, and process improvements . What Makes This Role Exciting In this position, you'll have the opportunity to: Lead and support critical sterilization and microbiological validation activities Develop additional expertise with gamma and electron‑beam sterilization Act as a technical resource for microbiology and new‑product initiatives Work closely with Quality, Manufacturing, Engineering, and other teams Participate in contamination‑control and environmental‑monitoring programs Contribute to investigations, CAPAs, and continuous improvement initiatives Gain exposure to both internal audits and external regulatory inspections Make a direct contribution to product quality, compliance, and patient safety Key Responsibilities As a Microbiologist II, you will perform and oversee a variety of laboratory and quality activities, including: Conduct microbiological testing such as bioburden, endotoxin, sterility, growth promotion, cell culture, and environmental monitoring Perform microbiological method validations for medical and non‑medical devices Lead and support sterilization validation activities in accordance with ISO 11137 Participate in dose audits, dose‑setting studies, dose mapping, and sterilization requalification Evaluate sterilization results and identify or elevate trends requiring further investigation Support the development and ongoing improvement of contamination‑control and facility‑monitoring programs Assist with facility gowning requirements and programs Serve as a microbiology resource and subject matter expert (SME) for new‑product activities Prepare and maintain SOPs, laboratory procedures, validation protocols, and technical reports Review and trend microbiological laboratory data for quality and management reporting Perform testing on returned or nonconforming products in support of investigations and complaint resolution Participate in deviation investigations, root‑cause analysis, and CAPA activities Work cross‑functionally to resolve microbiological and product‑quality concerns Support internal quality audits and external regulatory inspections Provide training related to aseptic technique, hygiene requirements, and microbiological practices Coordinate specialized testing with outside and third‑party laboratories Maintain appropriate laboratory inventory, equipment, supplies, and consumables Use SAP to support purchase requisitions and material‑transfer activities What We're Looking For The ideal candidate will bring a strong foundation in microbiology along with experience working within a regulated laboratory environment. Qualifications include: Bachelor's or master's degree in Microbiology or a related scientific discipline Minimum of 3 years of relevant experience in a GMP‑regulated laboratory environment Medical device, pharmaceutical, life sciences, or comparable regulated‑industry experience preferred Experience or working knowledge of gamma and electron‑beam sterilization Knowledge of ISO 13485 and ISO 11137 Understanding of medical‑device regulations and applicable quality requirements Experience with microbiological testing, validation, and laboratory documentation Strong technical‑writing, analytical, investigation, and problem‑solving abilities Proficiency with Microsoft Word, Excel, Outlook, and laboratory‑based computer systems Ability to independently manage responsibilities while collaborating effectively with cross‑functional teams Benefits We offer a competitive total rewards package that includes: Competitive compensation Medical insurance Paid time off in accordance with company policy 401(k) with a 5% company match Pay Details: $60,000.00 to $75,000.00 per year Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr