
Operational Readiness Specialist
2 weeks ago
We are seeking an experienced professional to join our team as a Solutions Architect.
As a key member of our organization, you will be responsible for ensuring the operational requirements of our buffer/media and material preparation areas are met through equipment onboarding, process readiness, and cross-functional coordination.
Key Responsibilities- Support startup activities for buffer/media and raw material preparation areas, including equipment verification, commissioning, and handover.
- Lead protocol writing, execution, review, and coordination of validation activities.
- Participate in process and layout design reviews, ensuring alignment with manufacturing operational needs.
- Work collaboratively with Engineering, Manufacturing, Quality Assurance, and CQV teams to ensure readiness for GMP operations.
- Assist in the development, review, and implementation of operational documentation, including SOPs, batch records, and work instructions.
- Coordinate mock runs, operator training, and readiness assessments to support go-live milestones.
- Provide support for material movement, staging, and flow strategies within cleanroom environments, ensuring compliance with GMP standards.
- Facilitate issue resolution during equipment startup and process simulations, escalating as needed.
- Bachelor's Degree in Engineering, Life Sciences, or related discipline from a recognized institution.
- 3-7 years of relevant experience in pharmaceutical, biopharmaceutical, or related manufacturing environments.
- Experience with buffer/media preparation processes and raw material handling.
- Well-versed in equipment, process, cleaning, and computer system validation (CSV).
- Prior involvement in facility startup or brownfield/greenfield expansion projects is preferred.
- Knowledge of GMP regulations and cleanroom operations is required.
- Able to work collaboratively with cross-functional teams and external vendors.
- Generous Leave Policy.
- Comprehensive Health & Wellness Coverage.
- Professional Development Opportunities.
- Inclusive Culture.
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