Job Summary:

The Manufacturing Technician I is accountable for results in a fast-paced environment and assists with the manufacturing of drug products (parenteral or solid dosage) for commercial distribution and clinical trials. The Manufacturing Technician I assists with the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Technician I employs acceptable techniques while working in manufacturing environments, including PPE gowning. The Manufacturing Technician I works collaboratively to support other manufacturing areas as required.

On-Site Expectations: 

• 100% on-site position.
• 3rd shift: Sunday through Thursday 11:00pm – 7:30am

Responsibilities:

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Assists with applicable manufacturing techniques and technologies per SOPs and cGMPs.
• Assists with manufacturing technologies and operation of manufacturing and material handling equipment.
• Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs.
• Performs in-process testing, weight checks, component counting, and basic math calculations.
• Performs cleaning of rooms, tools and equipment.
• Assists with other manufacturing areas as required.

Manufacturing Technologies for Sterile Liquids:

• Equipment and component preparation and sterilization 
• Compounding
• Aseptic filling 
• Capping

Qualifications:

• High school diploma or GED required. Associate’s degree preferred.
• Entry level, 0-1 years of work experience required; 1-2 years of relevant experience preferred.
• cGMP or prior work experience in a regulated environment preferred.
• Prior pharmaceutical or CDMO experience preferred.

Knowledge, Skills, and Abilities:

• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Ability to perform basic math calculations.
• Ability to read and comprehend detailed written instructions required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Proficiency in basic computing skills required.
• Awareness of or prior experience with cGMP practices and procedures preferred.

Travel Expectations:

• Up to 5% domestic travel.

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met or encountered 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. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, occasionally lift and/or move up to 50 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this job, the employee is frequently exposed to moving mechanical parts; fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Other tasks involving elevated work may require the use of a body harness and lanyard. Additionally, the employee may be required to operate an industrial vehicle.