Microbiologist I
Microbiologist I
Posted on :
17-05-2025
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1 Vacancy
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Job Description
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fillfinish services. From IND applications through commercial scale production we provide formulation and compounding fillfinish and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team s expertise to create a process design for our clients products that best suits their needs.
The Experience
With operations spanning the globe and featuring a multicultural team BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team you will be offered the ability to feel inspired in your career explore your professional passions and work alongside a group of people who will value and nurture your talents.
Your Role
We are hiring a motivated and detailoriented Microbiologist I. This role will support microbiological testing and environmental monitoring activities to ensure compliance with cGMP and regulatory standards.
- Perform routine microbiological testing including endotoxin bioburden sterility testing media growth promotion environmental monitoring and critical utilities collection and testing.
- Conduct environmental monitoring including viable air and surface sampling nonviable particle monitoring etc.
- Perform trending and data analysis with appropriate statistical evaluation of environmental monitoring.
- Perform and document investigations for environmental monitoring excursions and incidents during aseptic filling routine monitoring.
- Perform required risk assessments and participate in investigations of microbiological deviations and outofspecification (OOS) results.
- Write review and approve standard operating procedures and coordinate/execute method development and method validation.
- Document all activities in accordance with Good Documentation Practices.
- Support the QC Microbiology group in internal audits external client audits and global regulatory audits as needed.
- Coordinate and assist in the validation calibration and maintenance of laboratory instrumentation and equipment.
- Maintain laboratory supplies equipment calibration and cleanliness.
- Adhere to all safety and compliance protocols.
- Additional responsibilities as assigned.
Requirements
- Bachelor s Degree in related scientific discipline Microbiology preferred.
- 23 years of experience in QC Microbiology function within the pharmaceutical industry.
- Prior experience in aseptic manufacturing environment is preferred.
- Understanding of aseptic technique processes and compliance.
- Understanding of industry regulations and compliance.
- Experience with disinfectant efficacy studies is a plus.
- Experience working in biosafety cabinets.
- Excellent communication skills both verbal and written.
- Strong attention to detail and organizational skills.
- Excellent analytical and problemsolving skills.
Benefits
Offering a full suite of benefits BioTechnique is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance so you not only enjoy your work but also have the time and resources to live your life happy and healthy.
Medical Dental and Vision PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs Basic Life Insurance Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO Sick Time and Paid Holidays
Education Assistance
Pet Insurance
Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness 24Hour Fitness and more)
Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees interns and applicants for employment. Consistent with this commitment our policy is to comply with all applicable federal state and local laws concerning employment discrimination. Accordingly the Company prohibits discrimination against qualified employees interns and applicants in all aspects of employment including but not limited to: recruitment interviewing hiring (or failure or refusal to hire) evaluation compensation promotion job assignment transfer demotion training leaves of absence layoff benefits use of facilities working conditions termination and employersponsored activities and programs including wellness social and recreational programs. Employment decisions will be made without regard to an applicant s employee s or intern s actual or perceived: race color religion sex (including pregnancy gender identity and sexual orientation) national origin age (40 or older) disability genetic information or any other status protected by law.
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Bachelor s Degree in related scientific discipline, Microbiology preferred. 2-3 years of experience in QC Microbiology function within the pharmaceutical industry. Prior experience in aseptic manufacturing environment is preferred. Understanding of aseptic technique, processes, and compliance. Understanding of industry regulations and compliance. Experience with disinfectant efficacy studies is a plus. Experience working in biosafety cabinets. Excellent communication skills, both verbal and written. Strong attention to detail and organizational skills. Excellent analytical and problem-solving skills.
Employment Type
Full Time
Key Skills
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