Genezen

gene therapy

MicrobiologyTechnician

Fishers, Indiana, United States CONTRACT
The Brief

“Microbiology Technician at Genezen. Skills: Environmental Monitoring (EM), Personnel Monitoring, pharmaceutical cleanrooms, microbiology laboratory responsibilities, cGMP/GMP policies, standard operating procedures, aseptic technique. Environmental Monitoring (EM) and Personnel Monitoring for pharmaceutical cleanrooms and the associated spaces including general microbiology laboratory responsibilities. Ensures strict adherence to all cGMP/GMP policies and standard operating procedures”

What You'll Achieve.

ensures completion within the applicable due dates; accelerating our partners' programs

Industry & Context.

gene therapy
Problems you'll solve

collaborative problem solvers

Eligibility Requirements

Work Environment Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning, Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities, Occasionally exposed to moving mechanical high, precarious toxic or caustic hazardous and risk of electrical shock, Occasionally exposed to extremely loud noise levels, Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required, Movement Frequently required to sit; use hands to finger, handle, or reach with hands and arms, Occasionally required to climb or and stoop, kneel, crouch, or crawl, Lifting Frequently lift and/or move up to 10 pounds, Occasionally lift and/or move up to 25 pounds, Vision Frequently utilize close vision and the ability to adjust focus, Physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job, Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

What They're Looking For.

Must Have

1+ years of relevant industry experience in laboratory or clean room environment, Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential, Adaptability required as work schedule may change based on business needs, Criminal background check required

What You'll Do.

Environmental Monitoring (EM) and Personnel Monitoring for pharmaceutical cleanrooms and the associated spaces including general microbiology laboratory responsibilities

Ensures strict adherence to all cGMP/GMP policies and standard operating procedures

Collects routine daily

and monthly samples in pharmaceutical cleanrooms

Sample types include air viable

and air nonviable monitoring

Collects compressed gas samples to ensure they are free of microbial and chemical contamination

Ensures aseptic technique is always adhered to during performance of work

Clearly documents sample collection activities according to cGMP/GMP procedures

Performs assigned sampling tasks carefully and on schedule according to standard operating procedure and supervisor instruction

Incubates all samples according to standard operating procedure

Reads and records sample results according to standard operating procedures

Notifies supervisor in a timely manner of any Alert or Action Level excursions

Participates in company sponsored training

Responsible for the performance of quality items (i. e. – DARs

etc.) ensuring completion within the applicable due dates

Responsible for the performance (if/when applicable)

review and approval of laboratory investigations

Performs Environmental Monitoring process qualification sampling

Ensure safe working environment and compliance with OSHA

and cGMP procedures and policies within the QC functional area

How You'll Work.

Team & Collaboration

communicates effectively with other departments; teamwork is essential

Communication Scope

Communicates effectively with other departments; communication by talking, hearing, using telephone and e-mail

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