The Setup Technician is responsible for maintenance and operational support of production scale industrial equipment needed for the manufacture of parenteral pharmaceuticals.
Additional duties will include parts and tool management, plant, and manufacturing equipment support.
Responsibilities:
• Comply/adhere with cGMP regulations, policies, SOPs, and batch records.
• Installs, maintains, operates, repairs, and troubleshoots equipment.
• Coordinates contracted maintenance activities with vendors.
• To identify, investigate, participate in and when necessary to take ownership of compliance issues and deviations when discovered and to support the identification and implementation of corrective and preventive actions (CAPAs).
• To work cooperatively with the Quality Assurance and other internal departments to ensure appropriate coordination of manufacturing activities.
• To ensure that all SOPs, batch records, manufacturing logbooks and other related documentation are completed according to GMP and Good Documentation Practices.
• Perform other duties as assigned.
Physical Demands:
• Ability to work in or nearby either chemical/pharmaceutical research or chemical/pharmaceutical.
• Must be willing and able to have potential limited exposure to hazardous chemicals.
• Ability to travel between and within facilities to visit staff, operations, and projects as needed.
• Ability to sit, stand, climb stairs and climb ladders to mezzanines when necessary
• Ability to lift up to 40 pounds
Requirements:
• HS Diploma or equivalent combination of education, training and professional experience
• 3 years or more related work experience (GMP / Bio-Pharma maintenance/engineering); clean room experience or experience in a similarly regulated industry
• Experience setting up pharmaceutical production equipment
• Proficiency with math, the metric system, weight and volume measures
• Must be able to comprehend and follow all applicable SOPs
• Must live within a commutable distance to Hunt Valley, MD
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com
Job Type: Permanent Post Date: 03/22/2024
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