Specialist Manufacturing F0018

Company Overview

Our company specializes in providing Integrated Engineering, Maintenance, Utilities and Specialized Technical Services for the Pharmaceutical, Parenteral, Chemical, & Medical Devices Manufacturing business sectors in compliance with Federal Government Regulations.

Qualifications and Skills

Bachelor's degree in Life Sciences or Engineering and five (5) years of Manufacturing Operations experience.
Critical Investigation Skills
CAPA Management
Risk Assessments
Strong Technical Writing skills in English
Detailed technical understanding of bioprocessing unit operations
Skilled in performance of GMP production operations
Regulatory knowledge and interactions
Participate and help lead cross-functional teams
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
Organizational and presentation skills
Basic project management skills
Basic knowledge of control charting

Responsibilities and Duties

Serve as a document owner

Non-Conformance and CAPA:
Authoring investigation reports
Execution of corrective actions
Review equipment/system Root Cause Analysis investigations

Process Monitoring and Process Validation:
Support establishment of process monitoring parameters and control limits
Collect process-monitoring data and support the assessment of deviations
Provide support of timely execution of the process monitoring quarterly reports
Assist with generation of process validation protocols and reports.
Assist with the execution of the process validation
Support collection and analysis of process validation data.
New Product Introductions & Process or Equipment Modifications:
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications
Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects

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