Job Description

Job Title: Assistant Project Coordinator

Location: Research Triangle Park, NC

Duration: 06 Months (possible extension)

Project Overview

This position will support the Large Scale Manufacturing (LSM) Modernization project for bringing a new Manufacturing Execution System (MES) to the drug substance manufacturing area. This system will encompass several phases covering electronic equipment tracking, electronic batch records and release by exception functionalities. This role will be supporting the operational readiness workstream and activities associated with ensuring the site is ready to receive this change and sustain it within routine production operations.

Job Summary

The Manufacturing Technology Operations (MTO) project support role will be responsible for assisting in daily activities related to the internal large-scale manufacturing (LSM) modernization project bringing MES and electronic batch record implementation to the site. This role will work with the current internal MTO group to support site documentation activities, meeting attendance, action tracking, design questions and batch record traceability mapping in addition to other assignments as required by group management. This role is technical in nature and requires a strong understanding of drug substance manufacturing and documentation generation and processing within a digital document management system. This role will interact with newly designed / validated MES system and the associated documentation supporting these systems.

Working Conditions

• This position will be based on-site at an operational pharmaceutical facility in Raleigh, NC
• Regular interaction with project teams, contractors, and site operations staff will be required.
• Ability to work in an open office environment with frequent distractions.
• Mon – Fri, standard work weeks and hours with occasional overtime as needed.
• On site presence for stand work weeks

Duration / Location

• Position will initially be for a 6-month contract with a possibility of extension dependent on project needs and colleague performance
• Position will be located at the *** facility in Raleigh, NC
• Position requires on-site presence, 5x days per week

Minimum Education Requirements

• Bachelor's degree in engineering, science, or other technical field of stud

Minimum Experience Requirements:

• Proven work experience within a manufacturing technical operations support group or other similar role with 5 or more years of experience within the pharmaceutical, biotech industry
• Experience working in a large molecule, drug substance facility
• Experience working on or with Manufacturing Electronic Systems (MES) or electronic batch records implementation projects is desired
• Familiarity with regulatory requirements in the pharmaceutical industry (GMP, FDA, EMA)
• Strong technical writing skills
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
• Strong analytical and problem-solving skills, with attention to detail.
• Organized, and detail-oriented with ability to manage multiple tasks simultaneously in a fast-paced environment.
• Demonstrated ability to work within a highly regulated, compliance-driven setting.
• Experience working within a matrix teams' environment
• Proficiency with MS Office suite of products and other software platforms
• Proficiency in myCIMS or Veeva document management systems a plus

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