Improve the technical capabilities and quality practices within the department
Coordinate activities and resolve issues across the department, other groups, and/or projects
Respond to and/or resolve recurring technical or processing issues
Develop and implement novel approaches to solving non-routine technical problems
Communicate information effectively through updates, reports, and summaries
Lead improvements in processes and methods that reinforce cGMP within the department and/or across the site
Participate directly in internal, external, and global health authority audits/inspections
Apply systematic thinking processes and technical knowledge to independently address a broad range of non-routine to moderately complex problems
Conduct investigations, demonstrate strong technical and problem-solving skills, and excellent technical writing skills
Provide training and guidance on the staff to meet the goals of the department
When appropriate, assist in providing leadership on project teams
Represent the department as the SME and lead multi-disciplinary teams or committees
Provide routine updates on progress, status, and issues associated with campaigns/projects
Provide support and/or direction to junior staff when necessary
Exercise sound judgment when making decisions
Make critical decisions in collaboration with key stakeholders
Demonstrate accountability for personal, departmental, and organizational initiatives
Requirements
BA / BS in a science or engineering related discipline (Biology, Chemistry, Biotechnology, Biochemistry, Biomedical Engineering, Chemical Engineering, Pharmaceutical Manufacturing, Process Engineering)
minimum 4 years plus years of experience or an Associate’s degree and 10 plus years of experience in a GMP manufacturing environment
Previous hands-on experience in a regulated (eg GMP/Aerospace) operations environment
Experience in investigating and helping to resolve production non-conformances, implementing CAPA, and leading improvement projects
Strong proficiency in Microsoft Word, Excel, PowerPoint
Familiar with other operations enterprise systems such as DeltaV, MES, and SAP
Strong leadership, organizational, communication, technical and writing skills
Benefits
discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
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