Xcelience.com

JOB TITLE:  Technician I – Manufacturing

REPORTS TO: Supervisor, Manufacturing

POSITION SUMMARY

Perform cleaning, equipment assembly/set-up and document entry activities. Support process and facility operations by complying with company and FDA cGMP requirements.

ESSENTIAL FUNCTIONS

• Process Related: Perform batch instructions to include dispensing of materials, operation of minor process and blending equipment, physical testing, product inspection, packaging, and general support of the manufacturing operation.

• Cleaning Related: Room cleaning, equipment cleaning and storage of related parts.

• Administrative Duties: Training on SOPs to remain current for job requirements, logbook entries and GMP documentation.

• Maintenance Related: Perform preventative maintenance, minor repairs to equipment, equipment set-up and daily checks to support the manufacturing operation.

EDUCATION AND/OR LICENSES MINIMALLY REQUIRED

• HS diploma, AAS preferred

• 0 – 1 year experience in a GMP pharmaceutical manufacturing environment

• Basic computer and math skills required

• Good written and oral communication skills

• Good mechanical aptitude

• Knowledge of metric system preferred

• Able to lift up to 25 kg (55 lbs)

PHYSICAL ABILITIES

The physical requirements described below are representative of those required to successfully perform the essential functions of the job. Where possible, reasonable accommodations may be made to allow an individual with disabilities to perform the essential functions.

MENTAL ABILITIES

The mental requirements described below are representative of those required to successfully perform the essential functions of the job. Where possible, reasonable accommodations may be made to allow an individual with disabilities to perform the essential functions.

WORK ENVIRONMENT

• Hot, noisy, dusty environment

• Extended use (> 8 hrs/day) of PAPR (Powered Air Purifying Respirator)

• Long periods of standing

• May be exposed to hazardous substances

TOOLS & EQUIPMENT USED

• All minor pharmaceutical process and blending equipment

• All pharmaceutical manufacturing test equipment

• Hand tools

• Computer

PERSONAL PROTECTIVE EQUIPMENT REQUIRED

• Safety Glasses and/or Face Shield

• Safety Shoes and/or Boots

• Gloves

• Respirator

EXPECTATIONS

Employees are expected to support Xcelience’s Core Values by exhibiting the following behaviors: mutual trust, genuine concern and respect for people, integrity and commitment to excellence. Additionally, employees are expected to comply withXcelience’s policies and procedures, and to conduct themselves in a professional manner at all times.