Microbiologist jobs

This position is responsible for providing reliable and expedient results from the testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities in compliance with all regulatory requirements, company policies and procedures in compliance with cGMP and SOPs.

• Responsible for analysis of incoming materials, intermediates, finished products, swab samples, water samples, environmental monitoring samples, and other samples as needed.
• Responsible for preparing, maintaining, and reviewing data.
• Responsible for assisting senior personnel in investigations and root cause analysis for microbiology related deviations. Assisting senior personnel with laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
• Responsible for assisting senior personnel with revisions to documentation (including the use of Change Control) such as Standard Operating Procedures, Test Methods, and Specifications.
• Responsible for assisting senior personnel with method suitability for compendial methods.
• Responsible for assisting senior personnel in the execution of complex projects such as method transfers, validations, and regulatory reports.
• Responsible for assisting senior personnel in projects of an advanced scope and complexity as assigned.
• Responsible for assisting senior personnel with communications with multiple departments including manufacturing, planning, and regulatory affairs.
• Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires a Bachelor’s degree, preferably in Microbiology or Biology, or equivalent education/experience.
• Prefer one to two years of relevant experience in a regulated laboratory environment.
• Prefer working knowledge of cGMP, DEA, and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Prefer experience with nonsterile pharmaceutical microbiology testing: Microbial Limits Testing (MLT)
• Prefer experience with water testing and environmental monitoring

Skills/Knowledge/Abilities:
• General understanding of the principles of microbiology as it applies to sterilization, bioburden testing, media preparation and qualification, aseptic technique, general traditional microbiology laboratory techniques.
• Experience with Gram staining and basic microscopy
• Computer proficiency with comprehensive working knowledge of MS Office products
• Ability to manage priorities and reporting requirements.
• Ability to perform routine tasks without direct supervision and perform non-routine tasks with some oversight
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and other internal stakeholders.
• Self-directed with ability to organize and prioritize work.
• Detail oriented with ability to analyze information, create metrics and articulate the link to business needs/objectives.

Problem Solving:
• Proactively works on problems of a moderate scope where evaluation of contributing factors requires the analysis of situations or data and knowledge of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
N/A

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

This position is responsible for performing routine and complex microbiological testing on surfaces, air, compressed gases, steam and purified water and is responsible for interpreting and reporting results. This position is also responsible for monitoring and compiling data for quarterly and yearly reports used to track and trend the EM activities, and preparation of media and reagent. This position will serve as the SME for micro and ensure all activities are performed in compliance with regulatory requirements and company policies and procedures.

• Responsible for performing the environmental monitoring of the designated areas and support facilities during and after production.
• Responsible for collecting, testing, interpreting and reporting results for water, steam, air and compressed gases for micro testing.
• Responsible for performing and qualifying disinfectant studies.
• Responsible for validating microbiology test methods.
• Responsible for trending and various assessments/reports as required, e.g. quarterly and yearly reports.
• Responsible for assuring that required media is available and that the necessary qualifications are met, e.g. growth promotion.
• Responsible for conducting microbial identifications, whether by in-house methods or preparing and sending off-site.
• Responsible for lab organizational/operational set-up and qualification.
• Responsible for supporting validation/qualification activities (process/equipment/facility).
• Responsible for developing, transferring and validating microbiology test methods.
• Responsible for creating and maintaining a library of microbial organisms.
• Responsible for preparing samples for shipment to contract labs as applicable.
• Responsible for drafting/amending Standard Operating Procedures (SOP) for the micro lab as needed.
• Responsible for preparing written reports of investigations as needed.
• Responsible for entering/reviewing data generated by other analyst(s) as needed.
• Responsible for supporting production, validation and quality assurance as needed.
• Responsible for completing training requirements and maintaining compliance with assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s), Work Instructions (WI) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:
• Requires Bachelor’s of Science degree with a minimum of 3 years relevant progressive experience in a microbiology laboratory with an emphasis on environmental monitoring activities.
• Experience in a manufacturing environment within pharmaceutical, medical device or nutraceutical industries is preferred.
• Understanding of cGMP is strongly preferred.

Skills/Knowledge/Abilities:
• Computer proficiency and working knowledge of MS Office products and systems such as EAM, SAP, Oracle, TrackWise and other computer relational databases.
• Self-directed with ability to organize and prioritize work.
• Detail oriented with ability to analyze information, create metrics and articulate the link to business needs/objectives.
• Interact positively and collaborate with co-workers, management and external partners.
• Communicate effectively with strong written and oral communication and technical writing skills.
• Ability to manage multiple priorities and reporting requirements.
• Ability to motivate, influence and lead others with and/or without direct supervisory authority.

Problem Solving:
• Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS: N/A

We offer a competitive benefits package, including:

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.

Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.