What are the responsibilities and job description for the Operations Lead, Packaging position at Scientific Search?
(Onsite in Cheney, WA area, 1st shift)
Company Profile: Global Pharmaceutical CMO
What You Can Expect To Do
Company Profile: Global Pharmaceutical CMO
What You Can Expect To Do
- Ensure operational excellence and continuous improvement within the shift manufacturing teams.
- Provide technical and operational support, maintain a strong working knowledge of the manufacturing equipment set, control systems, and site operating systems.
- Provide Subject Matter expertise on industry standards, best practices, and site capabilities to enable successful integration of new products and processed into the existing and future facility packaging equipment.
- Support and own development of packaging qualification process to include materials selection, packaging studies, and authoring procedures for ensuring packaging processes comply with cGMP guidance.
- Serve as a key integrator for cross-functional teams supporting seamless operation of cGMP production, ensuring readiness of manufacturing areas for start-up, process qualification, and validation activities.
- Support the manufacturing operations team as a key contributor for projects that implement new technologies and operational process improvements in the GMP manufacturing environment, maintaining processing suites in a compliant and validated state.
- Lead or participate in continuous improvement projects, including capacity optimization and cost reduction programs.
- Support the development of the Operational Excellence programs and lead Manufacturing Projects with cross-functional stakeholders.
- Work with cross functional teams to review, author and revise standard operating procedures and batch records, review technical reports, assist with conducting deviation investigations, and write deviation reports.
- Document and communicate all aspects of work and learnings, providing training and mentorship for new personnel; Assist with metrics tracking and reporting to leadership teams.
- Support and participate in internal and external regulatory inspections as necessary.
- Bachelors Degree in Packaging Engineering (must have)
- Experience in project management and coordination.
- Strong analytical skills and proficiency in data analysis tools and techniques.
- Ability to influence network with multiple levels and functions of the organization.
- Tasks require entering manufacturing areas which require wearing appropriate PPE.
- Microsoft Office and Production Planning
