Specialist Manufacturing

Responsibilities

• Support the execution of manufacturing and quality systems, including non-conformances, process validation, and new product introductions within a GMP environment.
• Initiate, revise, and approve manufacturing procedures to ensure they reflect current operations.
• Assess process performance through floor observation and data review to identify improvement opportunities.
• Provide troubleshooting support for manufacturing operations and assist in generating technical training materials.
• Manage non-conformances (NC) and CAPA closures, including authoring investigation reports and executing corrective actions.
• Support process validation activities by generating protocols, executing activities, and analyzing data.
• Participate in regulatory inspections, new product introductions, and process or equipment modification projects.

Requirements

• Doctorate OR Master's + 2 years experience OR Bachelor's + 4 years experience OR Associate's + 8 years experience OR HS + 10 years experience in Manufacturing Operations.
• Detailed technical understanding of bioprocessing unit operations.
• Strong knowledge of GMP production operations and regulatory expectations.
• Proficiency in technical writing and report development.
• Fluency in both English and Spanish.

Preferred Qualifications

• Background in Life Sciences, Biology, Chemistry, or Engineering.
• Proficiency with Root Cause Analysis (RCA) tools such as 5 Whys, Fishbone, or Kepner-Tregoe.
• Experience handling deviations, non-conformances, and investigations.
• Familiarity with Lean Manufacturing and continuous improvement methodologies.
• Experience with industry systems such as TrackWise, VEEVA, MES, SmartSheet, or Power BI.

Benefits

• 6-month to 1-year contract with the possibility of extension.
• Administrative Shift.

About the Company

BioPharma Consulting JAD Group provides specialized expertise and support to the biopharmaceutical industry, focusing on manufacturing excellence and regulatory compliance.