- Provide technical support for incident and deviation investigations for commercialized products at Perrigo facilities within Michigan
- Identify root causes of incidents and deviations
- Develop and implement corrective and preventive actions
- Collaborate with cross-functional teams to coordinate investigations and resolve issues promptly
- Conduct risk assessments to identify manufacturing-process improvements
- Use Lean Six Sigma methodologies and tools to drive continuous improvement
- Collect and analyze data to identify trends and improvement areas
- Stay current with industry best practices and technological advancements
- Support ODR activities by defining base equipment conditions, inspection points, and lubrication standards
- Partner with operations and maintenance to eliminate contamination sources and hard-to-access areas
- Provide technical guidance to strengthen equipment reliability and align ODR routines with continuous-improvement objectives
Requirements
- Bachelor’s degree, preferably in engineering, chemistry, pharmaceutical sciences, or a related field
- Knowledge of pharmaceutical sciences and manufacturing processes
- Well-developed interpersonal, organizational, and communication skills
- Ability to work effectively with staff members at all levels
- Strong technical writing skills
- Familiarity with cGMP and FDA regulations
- Familiarity with investigations and/or developing and recommending process improvements
- Experience with operator-focused reliability programs such as ODR, Autonomous Maintenance, or TPM preferred
- Computer literacy and working knowledge of Microsoft Office, including Excel and Word
- SAP experience preferred
- Ability to work independently on multiple concurrent projects with minimal guidance
- Ability to meet project deadlines
Core Competencies
Demonstrates expertise in technical support for incident investigations and process improvements within pharmaceutical manufacturing, utilizing Lean Six Sigma methodologies and a strong understanding of cGMP and FDA regulations.
Highest-signal resume keywords
- Lean Six Sigma Methodologies
- Pharmaceutical Sciences Knowledge
- Technical Writing Skills
- CGMP and FDA Regulations Familiarity
- SAP Experience
ATS Optimization Keywords
Hard Skills
- Incident Investigation
- Root Cause Analysis
- Corrective and Preventive Actions
- Risk Assessment
- Data Analysis
- Process ImprovementEquipment Reliability
- Manufacturing Process Knowledge
- Autonomous Maintenance
- Total Productive Maintenance
Soft Skills
- Interpersonal Skills
- Organizational Skills
- Communication Skills
- Independent Work
- Project Management
Industry Keywords
- CGMP
- FDA Regulations
- Continuous Improvement
- Operational Excellence
- Technical Guidance
Tools & Technologies
- Microsoft Office
- Excel
- Word
- SAP