Manufacturing Technician II

Role Summary

As a Manufacturing Technician II, you will implement all processes in production while strictly following cGMP, environmental health and safety guidelines and any applicable related regulations. You will have technical and administrative competence to organize and lead production activities. You will participate in both departmental projects and any quality working teams which may be applicable. Responsibilities include assisting with the movement of Flexbumin between the different stages of inspection to packaging within the value stream. You may be line lead, and will ensure the line operates smoothly and keeps up with daily goals. You will also document your process activities on routers or in the electronic batch management system (EBM). You will report to the Supervisor, Manufacturing.

Responsibilities

• Understanding of cGMP regulations in a pharmaceutical manufacturing environment.
• A self-starter with a positive attitude and good time management skills.
• Ability to remain professional at all times.
• Meet the deadlines of individual production tasks during shift.
• Follow the company’s safety and quality guidelines.
• Maintain a safe and quality working environment.
• Participate in Continuous Improvement Teams.
• Support manufacturing operations.
• Lead Manufacturing Technicians I in daily tasks.
• Operate general production equipment (such as Downstream Automated Packaging lines, forklifts, and hoists).
• Move pallets to different rooms within the value stream.
• Communicate and work cross-functionally with other departments.
• Receive and distribute supplies into the production area.
• Follow cGMP, environmental health and safety guidelines, and any other regulations.
• Complete relevant paperwork following GDP/GMP guidelines.
• Perform daily cleaning of the production area to maintain in GMP fashion.
• Train employees/contractors on procedures.
• Communicate issues related to safety, quality, compliance and equipment to the manufacturing lead operator and supervisor.

Qualifications

• High school diploma or GED; 2+ years of experience or AA or higher and 1+ years of related work experience.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment.

Education

• High school diploma or GED; 2+ years of related experience or AA or higher and 1+ years of related work experience.

Additional Requirements

• Must be able to carry up to 30lbs, lift up to 30lbs, push/pull up to 30lbs (with assistance of material handling equipment).
• Must be able to stand and/or walk for an extended period over an 8-12 hour shift between rooms and across the site.
• Must be able to walk within and between quality rooms and packaging rooms, as well as throughout the entire plant.
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
• Repetitive motions with hands, wrists, turning head, bending at knees and waist.
• Vision requirements: 20/20 near and distance with or without glasses or contacts (applies to roles performing visual inspection only); may not be colorblind (applies to roles performing visual inspection only).
• Work around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.
• Indoor working conditions and exposure to loud noises that require hearing protection.
• Will work around moving equipment and machinery.
• No makeup, jewelry, nail polish, or artificial fingernails may be worn in the manufacturing environment.
• Work in a controlled environment requiring special safety gear or gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body (applies to roles in Filling Department only).
• Some Clean Room and/or cool/hot storage conditions (applies to roles in Filling Department only).
• May be exposed to cephalosporin (applies only to product touch roles).
• Must be able to work on multiple shifts, including weekends, to support a 24/7 manufacturing operation as needed.
• Must be able to work non-traditional work hours, including weekends and holidays, as needed. Must be able to work a 12-hour shift (5:00pm – 5:30am).
• Requires flexibility to work during off shift hours and/or conduct activities in support of different shifts as needed.
• Must be able to work overtime as required.