Manufacturing Technology Specialist - OQSIE
St. Louis, MO 63146
About the Job
Job Description
Manufacturing Technology Specialist
Contingent Worker to perform as MFG Tech Specialist to effectively manage and coordinate aseptic manufacturing technical projects and functions at the facility in
support of technical projects and CAPAs.
Responsibilities:
• Partner with Sterile Product Manufacturing (SPM) principals, Quality Assurance (QA), Operational.
• Excellence (OPEX), and other internal experts to identify root cause and implement CAPAs and process solutions.
• Collaborate and provide technical guidance to QA and SPM operations related to technical or product investigations.
• As an individual contributor, represent manufacturing on assigned to project teams to ensure completion of key projects initiatives.
• Act as internal technical training resource for both SPM Management and SPM production floor team.
• Work with Quality Operations and Regulatory Affairs to ensure regulatory filings are completed on time and to the appropriate standard.
• Champion Process Change Proposals/Requests as relates to technical support operations.
• Provide support to manufacturing staff on the production floor to affect smooth scale-ups and technical Transfers (including execution of Manufacturing/ equipment testing) Anticipate potential problems, risks, and technical conflicts and develop necessary contingency plans that optimize business continuity.
• Ensure work activities are conducted in strict accordance with safety guidelines and processing Standards, such as FDA's current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs).
Qualifications:
• Bachelor's degree in Science or Engineering field (ideal Process Engineering)
• 5 - 7 years' Experience in Manufacturing and cGMP
• Able to translate audit findings, assessments, and gap analysis into recommendable actions to senior staff
• Must be able to work in a fast pace environment
• Strong analytical and problem solving skills
• Self-Motivated with a proven record of taking the initiative
• Able to work with minimal supervision
• Detail-Oriented with Excellent Oral and Written Communication Skills
• Able to execute tasks in a very dynamic and ever-changing environment
• Exercise sound judgment and ability to work effectively with a diverse workforce
• Microsoft Office Applications – Word, Excel, Access, PowerPoint, Outlook, Visio, etc.
Manufacturing Technology Specialist
Contingent Worker to perform as MFG Tech Specialist to effectively manage and coordinate aseptic manufacturing technical projects and functions at the facility in
support of technical projects and CAPAs.
Responsibilities:
• Partner with Sterile Product Manufacturing (SPM) principals, Quality Assurance (QA), Operational.
• Excellence (OPEX), and other internal experts to identify root cause and implement CAPAs and process solutions.
• Collaborate and provide technical guidance to QA and SPM operations related to technical or product investigations.
• As an individual contributor, represent manufacturing on assigned to project teams to ensure completion of key projects initiatives.
• Act as internal technical training resource for both SPM Management and SPM production floor team.
• Work with Quality Operations and Regulatory Affairs to ensure regulatory filings are completed on time and to the appropriate standard.
• Champion Process Change Proposals/Requests as relates to technical support operations.
• Provide support to manufacturing staff on the production floor to affect smooth scale-ups and technical Transfers (including execution of Manufacturing/ equipment testing) Anticipate potential problems, risks, and technical conflicts and develop necessary contingency plans that optimize business continuity.
• Ensure work activities are conducted in strict accordance with safety guidelines and processing Standards, such as FDA's current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs).
Qualifications:
• Bachelor's degree in Science or Engineering field (ideal Process Engineering)
• 5 - 7 years' Experience in Manufacturing and cGMP
• Able to translate audit findings, assessments, and gap analysis into recommendable actions to senior staff
• Must be able to work in a fast pace environment
• Strong analytical and problem solving skills
• Self-Motivated with a proven record of taking the initiative
• Able to work with minimal supervision
• Detail-Oriented with Excellent Oral and Written Communication Skills
• Able to execute tasks in a very dynamic and ever-changing environment
• Exercise sound judgment and ability to work effectively with a diverse workforce
• Microsoft Office Applications – Word, Excel, Access, PowerPoint, Outlook, Visio, etc.
Source : OQSIE