Job Detail

Job Description

JOB PURPOSE:

The Manufacturing Technical Operations Senior 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…
   - Investigating & Troubleshooting discrepancies on the floor, implementing corrective actions
   - Identifies improvement opportunities for MFG, suggests potential improvements and implements them
   - Support scheduling of MFG by ensuring production schedule reflects actual process


4. Support Training of MFG staff by writing, editing or designing training materials (may also include training MFG staff and Knowledge Sharing cross functionally)


5. Leads small to medium projects via cross functional teams and participates in major projects for the site

Qualifications

• Bachelor’s degree preferred. Other educational levels accepted based on related experience in the field.




• At least 5 years of relevant experience (additional experience required without Bachelor's Degree)




• Highly detailed oriented with excellent documentation skills and exceptional troubleshooting abilities




• Solid knowledge of business and manufacturing processes to support manufacturing operations




• Solid understanding of the basic QA and cGMP principles




• Solid understanding of the roles of various functional groups within the company and ability to influence




• Fundamental knowledge of change control




• Solid Project management skills




• Fundamental level of technical writing skills, Intermediate to advanced skills in Microsoft Office




• Ability to interpret and design manufacturing documents and/or instructions within enterprise systems as well as DCS and MES




• Excellent oral and written communication skills