Senior Microbiologist

4 weeks ago

Ridgefield, New Jersey, United States eTeam Full time
Job Title: Senior Microbiologist

Location: Ridgefield, NJ

Duration: 12 Months

Possible extension of 1 year.

Degree in Bio or Microbiology. 6 years experience in PHARMA.

Exceptional knowledge of USP, EU and ISO regulations a must.

Validation protocol writing, review and execution (or over seeing validation execution) - Micro-validation studies.

Job Description:
  • The Senior Microbiologist is dedicated to the Microbiology Laboratory and microbiology studies.
  • The role of the Senior Microbiologist will be that of a Subject Matter Expert for any lab or EM as related to Microbiology, Testing, Aseptic Practices, Environmental Monitoring for Controlled Facilities.
  • The candidate will review, author and execute Micro-validation studies.
  • The Candidate will mentor and educate the junior Analysts on matters directly related to lab operation and testing.
  • The Senior Microbiologist is part of the Quality Assurance Department at Ridgefield, NJ.
  • This role is responsible for providing direction, mentoring and completing high-level projects for the Micro team.
  • This position also includes product testing, release EM Monitoring, data review and validation.
Responsibilities:
  • Hours: Monday - Friday from 8:00 am to 4:30 pm.
  • Some flex in the start and end times may be allowed; weekend work and overtime as required.
  • Exceptional knowledge of USP, EU and ISO regulations a must.
  • The candidate must have previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays.
  • Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.
  • Validation protocol writing, review and execution (or over seeing validation execution).
  • SOP review, creation and approval.
  • OOS investigations writing/review and approval.
  • Mentor junior Analysts on testing, trouble shooting and Lab related items.
  • Ensure compliance with all cGMP standards, safety and environmental regulations and company SOPs.
  • Provide advice to subordinates based on general policies and management guidance.
  • Ensure that high-level projects are completed on schedule and accurately.
  • Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.
  • Participates in Change Control meetings as the Microbiology Subject Matter Expert and initiates change controls as required.
  • Support regulatory, third-party and internal audits when required.
  • Conveys complex information in a concise manner.
  • Motivate and Develop teams.
  • Interact with Project Teams and cross-functional groups related to site operations.
Requirements:
  • BA/BS in Microbiology/Biology with 6-10 years experience is required.
  • A thorough understanding of validation testing; write, execute and report validation studies.
  • Practical experience in general microbiology laboratory techniques working with bacteria, yeast and mold.
  • Prior experience with, writing protocols, data review, authoring SOPS, Change Controls, out of specification investigations and report writing.
  • Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing.
  • Excellent technical writing skills.
  • Ability to collaborate effectively with personnel and between departments.
  • Strong analytical and problem-solving skills.
  • Make sound judgement from data.
  • Strong communicator.
  • Works independently.
  • Working knowledge of Word, Excel and PowerPoint.
  • Preferred experience with a deviation/CAPA enterprise system.

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