Chemical Operator

POSITION SUMMARY

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility located in Riverview, Michigan, is seeking a qualified Chemical Operator II to join our Production team. The Chemical Operator II is responsible for conducting chemical syntheses/manufacture of active pharmaceutical ingredients (APIs), their intermediates and other materials according to applicable SOPs, batch records, and current Good Manufacturing Practices (cGMP).

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

• Conduct chemical syntheses of APIs and their intermediates within scheduled dates or times independently.
• Comply with all applicable policies and procedures. This includes those required by PPS as well as external regulatory bodies.
• Maintain cleanliness and routine maintenance of the work area and equipment items within the working environment.
• Maintain, operate and troubleshoot process specific utilities independently.
• Control the inventory of basic raw materials, consumables, and wastes within the immediate working environment.
• Document all work conducted according to ASI required format(s). Including but not limited to electronic systems.
• Recognize and report documentation issues to supervision and QA.
• Assist in the assembly and maintenance of documents particular to the operation and complying with applicable regulatory requirements.
• Assist supervision in support of the facility by:
  • Recognizing and reporting equipment issues to Supervisor and Maintenance.
  • Recognizing and reporting inventory issued to Supervisor and Purchasing.
  • Support site waste management.
  • Reviewing and generating supporting SOPs and records.

• High school diploma or equivalent.
• Two (2) year diploma from an accredited institution or equivalent experience strongly preferred.
• Two (2) years minimum experience as Chemical Operator I or equivalent experience in a chemical manufacturing environment.

• Mechanical skills in assembly and use of bay processing equipment and aides, as well as troubleshooting skills for all equipment.
• Good understanding of applicable software systems including but not limited to Trackwise, SAP, Master Control.
• Ability to interact effectively within all levels of the company.
• Self-starter with ability to recognize tasks that need to be completed and to adjust schedules in order to meet commitments.
• Excellent record-keeping and communication skills.
• Knowledge of job related regulatory requirements (cGMP, OSHA, and EPA).
• Must be able to pass a respirator fit test.