4 дня назад
Microbiologist (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Microbiologist (Biotechnology): Performing microbiological testing, environmental monitoring, and contamination control activities for sterile injectable manufacturing in a GMP-regulated environment with an accent on bioburden, endotoxin, disinfectant efficacy, and data integrity. Focus on method validation, OOS/OOT investigations, trend analysis, and leading complex laboratory projects.
Location: York, United States. Must be authorized to work in the U.S.
Company
operates BioTechnique, a full-service CDMO providing formulation, sterile injectable fill-finish, and lyophilization services from IND applications through commercial production.
What you will do
- Perform microbiological testing, sampling, environmental monitoring, and laboratory analyses under approved SOPs.
- Conduct disinfectant efficacy testing and bioburden, endotoxin, and related microbiological assays.
- Operate and maintain laboratory equipment and instrumentation.
- Document and review results while maintaining data integrity and supporting cGMP compliance.
- Perform method validations, qualifications, trend analyses, and investigations of OOS, OOT, and atypical results.
- Author technical documentation, lead complex laboratory projects, and mentor junior personnel.
Requirements
- Bachelor’s degree in Microbiology, Biology, Biotechnology, Biochemistry, or a related scientific discipline.
- 4–6 years of Quality Control Microbiology experience in a regulated pharmaceutical, biotechnology, or related industry.
- Knowledge of microbiological testing methods, environmental monitoring, contamination control, cGMP, and data integrity.
- Strong analytical, problem-solving, organizational, and communication skills with the ability to manage multiple priorities.
- Must be authorized to work in the U.S.
- No C2C at this time.
Nice to have
- Experience with method validation, investigations, trend analysis, LIMS, eQMS, or laboratory data systems.
- Leadership and mentoring experience for advanced-level responsibilities.
Culture & Benefits
- Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
- 401(k) plan with matching, paid time off, sick time, and paid holidays.
- Education assistance and fitness benefits.
- Life insurance, short- and long-term disability coverage, employee assistance programs, pet insurance, and financial discounts.
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