Parexel Keyword Location Search view all jobs Scientist III Microbiologist - FSP Harrisburg, PA Posted 85 days ago Apply Now We are looking to fill a microbiologist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in West Point, PA. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer any sponsorship. Qualifications Bachelor's degree required; concentration in a scientific or applied discipline strongly preferred, with 3-5 years of experience in pharmaceutical microbiology related position required; or a MS with 1-2 years of experience Required Skills and Experience Solid microbiology foundation with experience in performing product testing Proven technical writing skills (SOPs, protocols) Desired Skills and Experience Experience in the pharmaceutical/biotechnology industries preferred Experience with environmental monitoring and water testing preferred Responsibilities

MICROBIOLOGICAL PRODUCT ANALYSIS

Analyze samples and compile meaningful data Perform Investigations and prepare/respond to CAPA (Corrective and Preventative Action) Review, revise Test Procedures / Standard Operating Procedures Ad Hoc work Rotational on-call assignments

MICROBIOLOGICAL ACTIVITIES

Include (but not limited to): Receive, verify & Log in samples MLT (Microbial Limits Testing) Method Suitability testing Endotoxin testing Return templates and shipping paperwork when and where appropriate Compile and trend data Prepare and ship materials offsite for ID/testing (when applicable) Environmental monitoring Stock culture management and quality control of same Biological indicator management Bioburden testing Water sampling Microbiological media management and quality control of same Sterilization activities Research experiments as deemed appropriate by client management Method Validation/Qualification Other microbiological activities Rotational on-call assignments for responding to alarms

CALIBRATIONS

Execute "Before-Use" calibrations prior to performing testing Review calibration data within the ELN (Electronic Laboratory Notebook) Prepare and submit equipment for calibrations (offsite or onsite) Complete calibration/PM paperwork PROCAL Entries

GMP ACTIVITIES

Prepare GMP documentation as requested by management Perform laboratory sanitizations and ensure cleanliness of laboratory workspace Perform equipment sanitizations (incubators / hoods / refrigerators) Purchase supplies (GMP) Prepare and send documents to Records Center

INVESTIGATIONS

Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)] Inform management of non-conforming events

AUDITS:

Participate in audits (Regulatory, In-house, Corporate) Participate in self-inspections and safety inspections Retrieve data when requested by Microbiology management

TRAINING

Complete assigned training when required Ensure training is complete prior to performing tasks The role is intended to be a 40 hours per week position. About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us! #

LI-DK1 EEO

Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Apply Now Active Filters Scientist III Microbio... Harrisburg, PA Clear All Powered By Cookie Policy We use cookies to improve your experience on our site. To find out more, read our privacy policy Accept Cookies Decline Cookies