What You Will Achieve
- Implement changes within Operations; ensure compliance of manufacturing suites
- Support audits/inspections, risk assessments, and CAL OOTs
- Coordinate and perform compliance walkthroughs
- Own/perform low-risk change controls (including impact assessments) and participate in other change controls
- Own CAPAs, change actions, and revising SOPs; deliver multiple projects to on-time milestones
How You Will Achieve It
- Organize work to meet project deadlines; drive projects to completion
- Use operational/technical expertise to implement manufacturing changes
- Support urgent Planned Temporary Changes
- Maintain production-area compliance/audit readiness
- Perform monthly compliance walkthroughs and close follow-up actions
- Serve as functional area lead in the backroom; support audit response drafting/finalization
- Initiate and close CAL OOTs; perform/participate in risk assessments
- Drive continuous improvement in commercial manufacturing/change-management support
Here Is What You Need (Minimum)
- BA/BS (any years), or Associateβs (4+), or High School diploma/equivalent (6+ relevant)
- Knowledge of process equipment and manufacturing operations
- Ability to follow SOPs and regulatory guidelines; basic GMP understanding
- Strong organizational skills; technical documentation skills
Bonus (Preferred)
- Pharmaceutical industry experience; writing Change Controls; deviations as responsible person
- Veeva Vault, EAMS, PDOCs; Six Sigma/operational excellence
Physical/Mental
- Standing/walking in suites; don cleanroom gowns; safety precautions
- Express ideas in SOPs/assessments; use Excel/Word/PowerPoint
Schedule/Work Environment
- First shift, MonβFri; occasional off-hours support; on-site with occasional work-from-home
Application
- Last day to apply: July 3rd, 2026
Compensation/Benefits (as stated)
- Base salary: $68,600β$114,300; bonus target 7.5% (Global Performance Plan)
- 401(k) with match, retirement contribution, paid time off/leave; medical/dental/vision benefits.