Microbiologist II

Tolmar; Windsor (CO); On-site; USD 47,000 - 48,000; Full time

Job summary

Tolmar in Windsor, CO is seeking a microbiology laboratory professional to ensure product quality through environmental monitoring, aseptic gowning support, and routine GMP testing. The role involves clean room duties, PPE usage, and collaboration with cross-functional teams.

Responsibilities include preparing media, documenting batch records, performing test methods, and assisting with CAPA investigations.

Qualifications

• CGMP/GDP knowledge relevant to pharmaceutical labs.
• Experience with routine culture/molecular techniques, microbial identification, endotoxin and plating instruments.
• Familiarity with regulatory requirements for drugs and medical devices.
• Strong written and verbal communication skills.
• Ability to coach and mentor team members.
• Detail-oriented, capable of handling repetitive tasks.
• Ability to follow batch records and validation protocols.
• Comfort working in clean room environment and PPE.

Responsibilities

• Perform microbial testing in GMP/ISO environment.
• Support aseptic gowning qualifications and process simulations.
• Conduct environmental monitoring in lab and manufacturing areas.
• Prepare media and solutions and set up the lab.
• Maintain notebooks and write test methods and reports.
• Assist with investigations (CAPAs) and trend reporting.
• Train other specialists in MODA and viable sampling.

Skills

CGMP knowledge

GMP/GLP concepts

Microbiology lab techniques

Documentation & record-keeping

Communication skills

Training/mentoring others

Problem solving

Attention to detail

Batch records & validations

Education

Bachelor’s degree in Microbiology, Biology or closely related field

Job description

Windsor CO
9351 Eastman Park Drive
Windsor, CO 80550, USA

Windsor CO
9351 Eastman Park Drive
Windsor, CO 80550, USA

Core Hours: Tuesday - Saturday, 8:00 am - 5:00 pm

• Training hours may vary

Purpose and Scope

To ensure product quality as it relates to raw material, components, product and environmental microbial testing.

• Perform job in a laboratory and clean room environment requiring clean room gowning, including but not limited to:
• Company-provided Scrubs
• Shoe Covers and Sterile Boot Covers
• Hairnets (and beard covers as applicable)
• Tyvek Coveralls
• Gloves
• Full-face masks/hoods
• Goggles
• Chemical Protection PPE
• Assist in performing environmental monitoring in the general and aseptic manufacturing environment.
• Assist in performing aseptic gowning qualifications and participate in aseptic process simulations.
• Perform routine quality control product testing on pharmaceutical items under GMP and ISO conditions, including sterility testing in an isolator
• Perform utilities sampling and testing (compressed gas, steam, and water).
• Assist with the setup of the laboratory and management of daily lab operations (prepare media and solutions).
• Incubate and enumerate organisms on cultured media.
• Maintain stock cultures of bacteria and fungi.
• Maintain notebooks according to GMP guidelines. Preparation of reports and summaries
• Write and execute test methods and work instructions
• Execute test method transfers and instrument validations.
• Provide EM data support including entry, review and tracking of EM data.
• Assist with utility and facility qualifications.
• Assist with investigations (Excursions, CAPA) to aid in the determination of root causes for environmental excursions and lab deviations within and outside of the lab.
• Assist with trend reporting and data analysis.
• Assist with training other members of the microbiology department and aseptic operations on MODA and viable sampling processes and techniques.
• May perform other related duties as required and/or assigned.

Knowledge, Skills & Abilities

• Understanding of CGMP’s and GDP’s
• Experience with routine culture/molecular techniques, microbial identification procedures, endotoxin and bacterial plating instruments preferred.
• Some knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
• Strong verbal, written communication skills and computer skills are required.
• Provide necessary coaching, guidance, and mentorship to specialists and associates related to improvements of job performance.
• Interact with peers and members of other departments in team settings in a professional manner.
• Must be goal-oriented, quality-conscientious, and customer-focused.
• Knowledge of laboratory science principles, microbiology lab equipment and microbiology concepts.
• Ability to read, understand, and follow work instructions and laboratory test methods.
• Ability to work independently and cooperatively on a team.
• Effective troubleshooting and problem-solving skills
• Ability to stand for extended periods of time (up to 8 hours or more).
• Understanding of basic computer software
• Ability to maintain focus on detail-oriented, repetitive tasks.
• Ability to follow and understand written production records and validation protocols.
• Ability to work within multi-functional project teams and independently with minimum supervision.
• Ability to manage multiple projects simultaneously.
• Understanding basic math and writing skills to document production activities in batch records and/or logbooks.
• Must be able to keep accurate records and able to perform mathematical calculations.
• Ability to legibly complete required documentation.
• Strong attention to detail required for documentation in production documents.
• Capability to operate on a fast-paced manual process using environmental monitoring equipment.
• Maintain and train others on Aseptic technique and work in an aseptic environment.

Core Values

• This position is expected to operate within the framework of Tolmar’s Core Values:
• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor’s degree in Microbiology, Biology or closely related field required
• 2 or more years of laboratory experience including Microbiology within a regulated industry.

Additional Requirements

• Valid driver’s license and acceptable motor vehicle record required.
• May require overtime and occasional holiday work.

Working Conditions

• Working conditions may include standing for long periods of time in various manufacturing and laboratory areas, and desk work.
• Laboratory setting; will be exposed to bio-hazardous materials, hazardous waste, and pharmaceuticals.

Compensation and Benefits

• Pay: $34.00 - $35.00 per hour, depending on experience

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

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Licenses & Certifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.