Job Description

Job Description

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).

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

• 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.

KEY RESPONSIBILITIES.

• 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.

EDUCATION/EXPERIENCE.

• 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.

JOB COMPETENCIES.

• 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 toTrackwise, SAP, MasterControl.
• 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.

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