Job Detail

Job Description

JOB PURPOSE:

The Manufacturing Support Associate will support Manufacturing activities in regards to Compliance, Recipe Management, Documentation, Technology Transfer, and Training. An understanding of the manufacturing process and its equipment, current regulations, and cGMP’s are needed to perform this position effectively

MAIN ACCOUNTABILITIES:

1. MFG Documentation: Initiate and monitor manufacturing documentation including Guides, SOPs, Work Instructions and other document types
    


2. Recipe: Coordinates and/or Makes revisions to recipes, both in DCS and MES, including parameters, resource text (RTE text) and resource groups
    


3. Support of the manufacturing process(including on floor support as needed) and represents MFG in cross functional groups. This includes but is not limited to:
   a. Investigating & Troubleshooting discrepancies on the floor, implementing corrective actions
   b. Identifies improvement opportunities for MFG
   c. Support scheduling of MFG by ensuring production schedule reflects actual process
    


4. Support Training of MFG staff by writing, editing or designing training materials
    


5. Supports small projects by working in cross functional teams to collect data, analyze data, and execute various action items against set timelines. May lead some small projects via cross functional teams

Qualifications

• An understanding of the manufacturing process and its equipment, current regulations, and cGMP’s are needed to perform this position effectively


• 3 to 5 years experience in GMP  Production environment, ideally within Biotech/Pharma


• Bachelor’s degree in Biotechnologies / Pharma or Engineering Degree in Pharma/ Biotechnologies preferred