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Manufacturing Process Specialist

2 months ago

Derry, Pennsylvania, United States Piramal Group Full time
Job Overview

The Research and Development Operator plays a crucial role in the operation, maintenance, and cleaning of various equipment including blending, granulation, compression, and coating machinery, adhering to the relevant cGMPs and SOPs. This position involves rotating between the Pilot Plant and Manufacturing departments based on business requirements.

Key Responsibilities

- Efficiently operate, disassemble, assemble, and clean equipment.
- Perform housekeeping duties and ensure cleanliness and routine maintenance of the workspace and machinery.
- Utilize computer systems to read, review, and train on SOPs.
- Provide feedback on existing SOPs and suggest potential process enhancements.
- Participate in scheduling tasks and manage computer transactions/metrics for the department.
- Document operating data within batch records in compliance with cGDPs.
- Review and maintain production documentation (batch records, logbooks, etc.) for quality assurance and cGMP adherence.
- Troubleshoot production processes and escalate issues to the appropriate personnel.
- Identify and report manufacturing incidents, assisting in investigations and supporting CAPA initiatives when necessary.
- Foster productive, trusting, and respectful relationships across all organizational levels while consistently acting as a team player.
- Collaborate and communicate effectively with other departments, including quality, validation, and supply chain, to meet production objectives.
- Adhere to Piramal Pharma Solutions' Safety, Health, and Environmental policies and procedures.
- Maintain confidentiality regarding all client and development activities.
- Undertake additional duties as required by business needs.

Qualifications

Essential Requirements
  • High school diploma or GED is mandatory.
  • Equivalent education, training, and experience will be considered.
  • Experience in a pharmaceutical, chemical, biochemical, or food manufacturing setting is essential.
  • A minimum of 2 years in an industrial or manufacturing environment is preferred.
Physical Requirements
  • Ability to lift up to 40 lbs and occasionally handle drums weighing up to 300 lbs.
  • Capability to work safely with heavy machinery.
  • Regularly stand, walk, sit, use hands for manipulation, reach, talk, hear, and maintain good vision.
  • Ability to climb ladders, bend, stoop, and kneel as necessary.
  • Willingness to wear Personal Protection Equipment, including N95 respirators and Powered Air Purifying Respirators.
  • No allergies to chemicals or biological substances typically found in laboratory or production environments.