Production Technician

Job Title: Production Technician
Location: Indianapolis, IN
Duration: 12 Months+ (Possibilities of Extension)

First shift: Shift: 7 am - 7:30 pm = 2 days on 2 days off and every other weekend.
 
Job Description Summary:
This is a senior-level position in the bulk processing area. The employee will utilize experience and training to manufacture pharmaceuticals in a strictly controlled GMP environment. The employee will progress through several job functions and be required to demonstrate increasing skill levels.
 
Responsibilities:
• Learn, understand, and comply with all Company and GMP compliance policies/procedures.
• Learn and perform area sanitization procedures in a GMP Manufacturing facility (Formulation Rooms, Staging Areas, Raw Material Dispensing Room, and Airlocks).
• Learn and become competent in performing filter integrity testing.
• Learn and become competent in cleaning miscellaneous pieces of manufacturing equipment and vessels.
• Learn and perform raw material weighing (dispensing) and bulk formulation.
• Perform system maintenance PM’s / procedures.
• Become and maintain qualification for entry into the Aseptic Core in order to perform sterile filtrations, unload the autoclave, and complete Steam-in-Place operations as deemed necessary by area management.
• Perform other duties supporting the production schedule as assigned by area supervision.
• Execute tasks/operations with minimal supervision.
• Provide training/guidance/leadership for Production Technician I and II personnel.
• Supervise the activities of other members of the manufacturing team, taking full responsibility for results.
• Coordinate manufacturing activities with other support groups to receive components, batch records, QC results, etc.
• Conduct QTS nonconforming product investigations, identify corrective actions, and implement changes as needed.
• Place purchase orders and monitor supplies.
• Perform final batch record reviews before QA review.
• Attend mandatory annual hazardous waste training meeting(s) and demonstrate competency in that training by passing test(s) administered by the company or consultant providing such training.
• Performs special projects and other duties as assigned.
• As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training.
• Must immediately notify supervisor if affected by infectious disease or open lesions on the body, as individuals are not permitted to enter manufacturing areas or handle products if these conditions exist.
 
Product:
• This position has no direct reports.
 
Background Qualifications:
• High school diploma or the equivalent. B.S. degree in chemistry/biology/life sciences is a plus.
• Minimum of five years of experience using current Good Manufacturing Practices (GMP) in a regulated manufacturing facility pharmaceutical/biotech/diagnostic industry) with Processing experience.
• Adequate communication skills to read, comprehend, and discuss detailed GMP documentation (batch record instructions, Standard Operating Procedures, etc.).
• Extensive knowledge of and experience in bulk formulation along with equipment cleaning, preparation, and assembly are preferred.
• As persons in this role are engaged in the open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
• Strong attention to detail.
• Ability to perform arithmetic functions to accurately perform or check calculations required in manufacturing instructions.
• Leadership experience in training/directing others.
• Strong mechanical aptitude.
• Ability to troubleshoot, identify problems, and propose solutions.
• While performing the duties of this job, the employee is regularly required to use their hands and arms. The employee is frequently required to stand. The employee is occasionally required to sit; walk; stoop, kneel, bend, crouch, crawl, talk or hear.
The employee must regularly lift and /or move up to 10 pounds and frequently lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, and peripheral vision.
• Computer skills in Microsoft Office such as Word and Excel are a plus.
 
Qualifications/Experience:
• HS or Equivalent
• 5+ year’s experience in a production environment (chemical/pharmaceutical/biochemical).
• GMP, GDP, of 5 years or more. A bachelor's degree in pharmaceuticals or chemistry is preferred.
• SAP knowledge a plus