Manufacturing Process Technician

2 weeks ago

Malvern, Pennsylvania, United States Planet Pharma Full time

Position Overview:

*SHIFT - MON-THURS, 1PM - 11:30PM

The Manufacturing Process Technician is responsible for the micronization and milling of client-supplied materials, including both active pharmaceutical ingredients and excipients, in accordance with established procedures and regulatory guidelines. This role emphasizes adherence to company values and leadership behaviors in all interactions.

Key Responsibilities:

  • Micronization and milling of both hazardous and non-hazardous pharmaceutical materials.
  • Set up and operate production equipment while monitoring processes and documenting production in compliance with good documentation practices (GDPs).
  • Review and ensure the accuracy and completeness of documentation, including batch records and standard operating procedures (SOPs), and suggest revisions as necessary.
  • Work effectively in a regulated environment, strictly following standard operating procedures.
  • Read and implement defined SOPs and policies to execute tasks efficiently.
  • Maintain compliance with current Good Manufacturing Practices (cGMP), promptly reporting any non-routine events or deviations to the supervisor.
  • Conduct cleaning of the processing area and equipment to maintain a safe and compliant workspace.
  • Produce clear and thorough documentation that meets Quality Standards (Attributable, Legible, Contemporaneous, Original, and Accurate).
  • Demonstrate a willingness to adapt to change, learn new processes, and contribute to continuous improvement initiatives.
  • Engage in shift change meetings and participate in team discussions, offering suggestions for enhancements and involvement in projects.
  • Aim for 'First Time Right' in all operations.
  • Stay updated with compliance training and site-specific requirements.
  • Perform all duties in accordance with company policies and procedures.
  • This is a site-based position.

Performance Metrics:

  • Adherence to safety and quality protocols.
  • Product quality, throughput, and final yield metrics.
  • Attendance, punctuality, and reliability.
  • Work ethic and overall attitude towards daily operations.

Qualifications:

Education: High School Diploma or GED required.

Experience:

  • Dependability and eagerness to learn are essential.
  • Prior experience in manufacturing and regulated environments is preferred.
  • Willingness to work overtime on weekdays and weekends is a plus.

Knowledge and Skills:

  • Strong organizational skills and attention to detail.
  • Effective oral and written communication abilities.
  • Basic math skills and the ability to interpret data.
  • Capability to multi-task and prioritize effectively.
  • Openness to change and learning new processes.
  • Potential exposure to health and physically hazardous materials.
  • Personal protective equipment will be provided and must be worn in designated areas.
  • Prior production experience is advantageous.

Physical Requirements:

  • Physical strength, stamina, and dexterity are necessary, including the ability to lift or move items up to 44 lbs. (20kg) independently, or between 45 lbs and 76 lbs. (35kg) with assistance.
  • Ability to work safely with high potency active pharmaceutical ingredients (HPAPI) and novel compounds.
  • Capability to perform moderate physical labor, including lifting, climbing, bending, crouching, reaching, and twisting.
  • Ability to stand or walk for extended periods, up to 8 hours daily.

Pay Rate: $15-23/hr. Salary will be commensurate with experience.

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