Main Responsibilities:
- Serve as an individual contributor and active member of cross-functional teams supporting FFIP department and Continuous Improvement projects.
- Lead and support continuous improvement initiatives across the department.
- Provide project management support to cross-functional teams to ensure timely delivery.
- Act as the department interface for resolving project-related issues and facilitating progress.
- Drive project deliverables across the FFIP (Formulation, Filling, Inspection, and Packaging).
- Initiate, review, and approve documentation supporting project execution.
- Lead and execute Medium/Small-scale CI projects from initiation through closure.
- Track project milestones, deliverables, and KPIs to ensure timely completion.
- Collaborate with CI SMEs and operational teams to identify and implement process improvements.
- Prepare and present project updates to stakeholders and leadership.
- Support large-scale FFIP projects in conjunction with PMS (Portfolio Management Strategy).
- Assist in developing project charters, risk assessments, and communication plans.
- Monitor progress and escalate issues to project leads and FFIP leadership as needed.
- Act as an interface for technical transfers and other major initiatives.
- Ensure alignment with GMP, safety, and quality standards throughout project execution.
- Maintain project documentation and contribute to lessons learned and continuous improvement.
Basic Qualifications:
- Bachelorโs Degree required.
- 2+ years of experience in Continuous Improvement, Project Management, or Engineering (or related) in a cGMP-compliant pharmaceutical/biotech, medical device, food industry environment, or equivalent regulated setting.
- 100% on-site presence during regular workdays; occasional off-shift support remotely or on-site.
- Excellent written and verbal communication; able to work cooperatively with cross-functional teams.
Preferred Skills:
- Masterโs Degree.
- Collaborative team player.
- Familiarity with Qualipso Applications (Change Control, CAPA, Deviation management).