PURPOSE
The Manufacturing Technician I is responsible for adhering to the Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs) that are in effect assuring the quality and quantity of product produced. 

DUTIES AND RESPONSIBILITIES

• Assist in set up of production equipment including Encapsulation Machine including Tumble Drying, Drying Tunnel, and Printing Machine, Capsule Sorting Machine, Inspection Belt, and any other equipment required for manufacturing and packaging.
• Ensures the efficient and quality standards for the operation of production equipment. Responsible for equipment cleanings, set-ups, and changeovers.
• Assist with trouble shooting machines as needed during production runs to minimize downtime. 
• Performs or verifies batch record entries. Ensures batch records, equipment logbooks, and other relevant records are up to date.
• Monitors process and equipment, making necessary adjustments as needed or required, to maintain batch record specifications. Ensures that the equipment in the department is cleaned properly per standard operation procedures.
• Must be familiar with In-Process Testing Equipment and be able to test soft gelatin capsules for seam thickness, hardness, burst strength, weight etc. using testing equipment to ensure quality gel capsule production.
• Additional duties, such as Bottle Packaging, Supporting Formulations and Research and Development, as required. 

KNOWLEDGE, SKILLS, AND ABILITIES 

• Knowledge of Lean Manufacturing principles a plus.
• Knowledge and understanding of GMP’s and pharmaceutical manufacturing plant with experience with packaging or manufacturing is strongly preferred.
• Ability to read and interpret documents such as standard operating procedures, safety rules, company policies, maintenance instructions, and equipment manuals
• Ability to communicate effectively with both supervisors and co-workers 
• Ability to accurately calculate figures both standard and metric. 
• Problem solving skills. 
• Knowledge of other oral solid dose manufacturing technologies is a plus 
• Basic computer skills (Desktop Software) are required. 
• Ability to work overtime as required. (Late nights and weekends). 

MINIMUM QUALIFICATIONS 

• High school diploma or GED required 
• 1-3 years’ experience in a GMP compliant manufacturing setting  
• Associates Degree or College/Trade school credits 

SPECIAL FACTORS/WORKING ENVIRONMENT 
TRAVEL 
Travel may be required for this position. 

WORK ENVIRONMENT 
This position works within an GMP Manufacturing Environment, office environment and inside the plant. 

• Must be able to work in controlled environments requiring special gowning.   
• Will be required to follow gowning requirements and wear Personal Protective Equipment (PPE) over head, face, and hands, and arms.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments. 
• Pace may be fast and job completion demands may be high. 

PHYSICAL DEMANDS 
While performing the duties the employee is frequently required to sit, stand, walk, and reach with hands and arms; stoop, kneel, crouch or crawl; and see, talk, and hear. The employee must occasionally lift or move up to 50 pounds.  Specific vision abilities required by this job include close vision.