What are the responsibilities and job description for the Machine Operator position at KriGen Pharmaceuticals LLC d/b/a Dynamic Biologics?
: Machine Operator
Job Summary:
Ø To follow the company Quality policy, Quality management system including the Quality objects.
Ø To adhere with current Good Manufacturing Practice(cGMP), Good Document Practice (GDP), Standard Operating Procedure (SOP) & Data Integrity Principles.
Ø To involve and execute all manufacturing and engineering related equipment Qualification and its documentation.
Ø To read the SOP and understand the procedure like machine operation, Documentation, Area cleaning and sanitization, online documentation, Qualification activity and cross functional department activity.
Ø To handle the Production Area machine/equipment operation.
Ø To handle the Utility Area machine/Equipment operation (Steam generator, Chiller, Hot water generation, Air compressor and cooling tower).
Ø To start the machine operation and complete the operation within time and achieve the company goal.
Ø To involve the batch manufacturing activity as per production plan.
Ø To Provide the training to area subordinates and colleagues.
Ø To involve in filling area operation, printing machine operation, component preparation, leak testing, terminal sterilization, visual inspection and packing area as and when.
Ø To perform area cleaning and sanitization activities.
Ø Work in shift-wise operation, working in all three shifts (First, Second and third shift) rotation.
Ø To ensure the handover of shift-to-shift activities and charge Handover to shift reliever.
Ø To work in classified and non-classified area related activity.
Ø To follow the Production and engineering area SOP and Quality standards.
Ø To Involve in visual inspection activity and its documents.
Ø Maintain the utilities and manufacturing facility for audit and compliance.
Ø To involve in Batch packing activity and its documents.
Ø To follow SOP and BMR instructions.
Ø To follow discipline and ethics in company premises.
Ø To communicate with superiors for any abnormality related to production activity
Ø Works as a member of a team to achieve all outcomes.
Ø To follow all established regulatory, compliances and safety requirements.
Ø To do the work which is assigned to area supervisor or superior.
Ø To operate the utility equipment like water system, Boiler, cooling tower, Chiller, Hot water system, air compressor and machine maintenance work.
Ø Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
Ø To provide necessary support and input to R & D during product/process development, technology transfer and new product launches.
Ø Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
Ø All other relevant duties as assigned.
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience:
- Utility/Production area machine operation: 2 years (Preferred)
Work Location: In person