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Description:

Responsible for cleaning, sanitizing, operating, and maintaining process equipment used during the manufacture of sterile drug products and for completing the associated documentation. Duties also include cleaning, organizing, and monitoring manufacturing clean rooms.

Summary:

Responsible for performing routine tasks in manufacturing products with direct supervision.

Essential Duties:

Follow Production Batch Records (PBRs) to operate, monitor, and control equipment and process parameters during manufacture.Follow SOPs to clean, sanitize, and prepare process equipment and rooms for manufacturing. Complete PBRs, Log Books, Forms, and other documentation. Review SOPs and Forms to reflect the current procedures accurately.Maintain assigned manufacturing area under 5S.Assist with the training of other manufacturing team members.Assist with the execution of validation protocols for manufacturing/support equipment.Participate in the performance of routine preventive maintenance on facilities and equipment.Recommend manufacturing or facility-related improvement projects, continuous improvements, or cost savings opportunities.Work safely by site procedures.Adhere to cGMPs and SOPs.Other duties as assigned.

Knowledge, Skills, and Abilities:

Develop an understanding of GMPs and mechanical problem-solving skillsComplete two training module areas plus 50% in two more regions in the first year.Must have legible handwriting with a documentation error of less than 5%.Less than three Quality Events a year.Develops relationships and actively contributes to team results.Participates in team problem-solving when issues arise.Developing written and verbal communication skills.Able to be flexible, adaptable, and self-motivated in response to changing conditions and schedules.Escalate frustration to management when dealing with stressful situations.

Qualifications:

High School Diploma or GED.0 - 5 years of applicable experience working in a GMP pharmaceutical manufacturing environment or equivalent experience.Qualified to work with controlled substances.

Physical Qualifications:

The employee is regularly required to use hands to finger, handle, or feel objects, tools, or controls. The employee is regularly required to stand and walk; climb or balance; and stoop, kneel, or crouch. The employee must occasionally lift and/or move up to 60 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus. The employee must wear all required safety equipment and safely perform assigned work. The employee must use proper lifting techniques and be conscious of hazards around him/her. Must follow all GMP and safety procedures within the department.

Occupational Exposure/Risk Potential:

Work environment includes the ability to work with high potent chemical compounds, hazard materials, toxics, and control substances. Must be willing to adhere to stringent PPE requirements, safe work methods and practices for personal and product protection. Attention to detail instructions and following other safe practices are key requirements as well. Medical surveillance protocols and questionnaires may be part of some of the products to be manufactured.

LS1406153-NM_1739460808 To Apply for this Job Click Here