Mechanic Operator, CSO

Role Summary

Permanent Position - Mechanic Operator - 51I - CSO. Shift: 7 AM - 3:30 PM EST. Site: New Brunswick, NJ. Bldg # 107 (excluded). Rate: $46.35 / hour. The goal of Product Development within Global Product Supply (GPS) is to develop new drug candidates and the processes to manufacture them into commercial realities. This is achieved by designing and conducting a variety of experimental studies using the latest scientific methods and state of the art equipment and instrumentation. The development process is very dynamic with performance in both laboratory and process scale-up facilities. Scientific rigor, timeliness and compliance with all GMP and federal/state/local regulations are a necessity.

Responsibilities

• Daily assignments based on demonstrated technical competence of the mechanical/operator aptitude and the demands of the process, with priorities set by business needs.
• Follow written procedures and verbal instructions with strict attention to safety and quality.
• Accurately and timely execute and document activities and results; adhere to GMP, federal, state and local regulations.
• Collaborate with other employees to achieve departmental and company goals.
• Occupancy structure determines where work is conducted (site-essential, site-by-design, field-based, remote-by-design) and travel requirements as applicable.

Qualifications

• High school diploma or equivalent plus specialized (mechanical) training or partial college in a mechanical trade.
• Completion of accredited apprentice program or five years equivalent experience as a line mechanic within the pharmaceutical industry.
• Minimum of five years' CGMP experience in the pharmaceutical industry.
• Proficiency in the use of computer programs/systems is essential.
• Maintenance of skills and knowledge current with advances in Pharmaceutical Development; internal or external training as approved by management.
• Training will ensure Mechanic Operators receive relevant training; ongoing assessment after training; interactive modules may be used for competencies.

Skills

• Mechanical aptitude and hands-on experimental/work experience in dynamic development processes.
• Strong documentation and accuracy in recording operations.
• Ability to follow complex procedures and safety protocols; working knowledge of SAP or similar systems.

Education

• High school diploma or equivalent; specialized mechanical training or partial college in a mechanical trade; apprenticeship or equivalent experience in pharmaceutical manufacturing.

Additional Requirements

• Working conditions may include odors, fumes, dust, powders, oil, grease, and noise; physical effort including stooping, lifting, bending, and occasional heavy machinery lifting.
• Annual eye exams; biennial re-qualification; annual gown/respirator training and medical respirator clearance for handling potent compounds.
• On-site requirements may vary by occupancy type; some roles may require 100% onsite or hybrid work arrangements with at least 50% onsite.