Project Coordinator

• Coordinate and oversee manufacturing line installation, modifications, and equipment commissioning projects.
• Develop project timelines, schedules, and deliverables in alignment with company objectives.
• Track project progress, identify risks, and escalate issues to management when necessary.
• Ensure projects adhere to established budgets and timelines.

• Assist in equipment qualification and validation activities (IQ, OQ, PQ) as required.
• Support process integration and line optimization efforts for improved efficiency.
• Ensure all equipment and installations comply with cGMP, safety, and regulatory standards.

• Work closely with engineering, operations, maintenance, and quality teams to align project goals.
• Coordinate with external vendors, contractors, and suppliers for timely delivery and installation.
• Act as a liaison between internal stakeholders and external partners.

• Prepare and maintain project documentation, including project plans, risk assessments, and status reports.
• Ensure accurate documentation of equipment changes, validations, and project milestones.
• Support regulatory and audit readiness by maintaining compliant project records.

• Bachelor's degree in Engineering, Biotechnology, Industrial Engineering, or related field.
• 2+ years of experience in project coordination, preferably in manufacturing, biotech, or pharmaceutical industries.
• Strong knowledge of cGMP, FDA, and ISO regulatory requirements.
• Proficiency in project management tools (MS Project, Smartsheet, or similar).

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