Senior Microbiologist (Temp)
Senior Microbiologist (Temp)
Posted on :
20-05-2025
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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 W2Temp Senior Microbiologist in York PA. The ideal candidate will have a strong background in microbiological testing with specific expertise in disinfectant efficacy testing environmental monitoring and cGMP compliance.
- Design execute and interpret disinfectant efficacy studies.
- Perform routine microbiological testing including endotoxin bioburden microbial identification microbial limits testing sterility testing media growth promotion environmental monitoring and critical utilities collection and testing.
- Conduct and oversee 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 lead investigations for environmental monitoring excursions and incidents during aseptic filling routine monitoring.
- Perform and lead required risk assessments and 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 or Master s degree in Microbiology Biology or related field.
- 710 years of experience in QC Microbiology function within the pharmaceutical manufacturing industry.
- Experienced in designing executing and interpreting disinfectant efficacy studies.
- Experience with microbial identification methods.
- Prior experience in aseptic manufacturing environment with strong knowledge of aseptic technique processes and compliance.
- Advanced understanding of industry regulations and compliance.
- Experience with disinfectant efficacy studies and facility validation is highly preferred.
- Experiene working in biosafety cabinets.
- Excellent communication skills both verbal and written.
- Strong attention to detail and organizational skills.
- Excellent analytical and problemsolving skills.
- Ability to work both independently and collaboratively in a team setting.
Benefits
This a W2Temp position with potential extension. W2Temp positions include medical benefits and sick time benefits.
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 or Master s degree in Microbiology, Biology, or related field. 7-10 years of experience in QC Microbiology function within the pharmaceutical manufacturing industry. Experienced in designing, executing, and interpreting disinfectant efficacy studies. Experience with microbial identification methods. Prior experience in aseptic manufacturing environment with strong knowledge of aseptic technique, processes, and compliance. Advanced understanding of industry regulations and compliance. Experience with disinfectant efficacy studies and facility validation is highly preferred. Experiene working in biosafety cabinets. Excellent communication skills, both verbal and written. Strong attention to detail and organizational skills. Excellent analytical and problem-solving skills. Ability to work both independently and collaboratively in a team setting.
Employment Type
Full Time
Key Skills
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