The Position
- Support people, equipment, and processes for operations areas to meet business and regulatory requirements.
- Support training for lower-level peers.
- Demonstrate subject matter expertise in assigned area.
- Provide process solutions for moderate to high complexity issues.
- Serve as a back-up as needed for the Sr Process Professional.
- Mentor/coach junior team members.
Essential Functions
- Conduct in-depth deviation investigations and root cause analysis.
- Drive continuous improvements using Lean tools and Six Sigma methodologies/certifications.
- Own area content and process knowledge.
- Identify and implement process needs and improvement opportunities.
- Perform periodic reviews and reporting; collaborate across sites.
- Update and manage area master data and recipes as needed.
- Support defined issues using expertise and knowledge.
- Follow all safety and environmental requirements.
- Other duties as assigned.
Qualifications
- Bachelorโs degree (engineering, technology, or related field) from an accredited university (required).
- OR Associateโs degree + 4+ years manufacturing experience (preferably pharma) (may be considered).
- OR High School Diploma/GED + 6+ years manufacturing experience (preferably pharma) (may be considered).
- Minimum 2 years manufacturing experience (preferably pharma).
- Excellent written communication; thorough investigation and systematic problem-solving.
- Lean manufacturing experience/training; knowledge of change control and QMS.
- Electronic manufacturing systems experience (e.g., SAP, PAS-X).
- Adult learning methods to train/coach (preferred).
- Regulatory audits/inspections experience (required).
- Relevant master data, validation experience (preferred); product/tech transfer (plus).
Physical Requirements
- Open office environment; frequent distraction.
- Travel up to 20%.
Benefits (if applicable)
- Leading pay and annual performance bonus; 14 paid holidays; health/dental/vision effective day one; 8% 401(k) contribution; paid parental (14 weeks) and family medical leave (6 weeks); tuition assistance; life/disability insurance; employee referral awards.