Manufacturing Process Specialist

4 weeks ago


Durham, North Carolina, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Manufacturing Process Specialist to join our team in the RTP Packaging area. As a key member of our team, you will be responsible for the safe operation of highly automated equipment producing products of the highest quality for our patients.

Responsibilities:
  • Adhere to RTP Plant safety policies and procedures, contributing to a safe work environment.
  • Setup and operate highly automated equipment in the Packaging area.
  • Adhere to standard operating procedures and current Good Manufacturing Practices to ensure quality of product.
  • Document process steps on appropriate batch documentation (Electronic Ticket, SAP, Cleaning Logs, etc.).
  • Attain and maintain qualification for the operation of assigned process equipment and duties in the area.
  • Identify opportunities for operational improvements.
  • Proactively monitor documentation and product quality, properly documenting all activities and reporting issues to supervision.
  • Contribute to the achievement of key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
  • Will begin as an 8hr shift with high likelihood to transition to work 12-hour shift schedule.
  • Currently in the startup phase of operations. Candidate must be flexible and be willing to perform non-routine work, with Safety & Integrity in mind at all times.
Requirements:
  • High School Diploma/GED required.
Preferred Skills:
  • Previous experience working in a GMP environment preferably in the pharmaceutical industry.
  • Strong ability to multitask.
  • Ability to demonstrate attention to detail.
  • Ability to develop independence in performing daily tasks.
  • Collaborative work ethic with a strong bias for action.
  • Demonstrated ability to train and coach others.
  • Ability to effectively communicate (written and verbal).
  • Flexibility and problem-solving skills.
  • Basic computer skills (desktop software) are required.
  • 3+ years relevant experience in pharmaceutical, or equivalent regulated industry.
  • Knowledge of current Good Manufacturing Practices (CGMPs).
  • Previous experience with Manufacturing Execution Systems and electronic batch release.
  • Knowledge of lean manufacturing principles.
Additional Information:
  • Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.).
  • Ability to work overtime as required.


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