Job Summary
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We are seeking a highly skilled Operations Support Specialist to join our team. The ideal candidate will have a strong background in biotech manufacturing and experience in project management, coordination, and training delivery.
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About the Role
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This is an exciting opportunity for a motivated individual to work closely with operations process teams, functional support personnel, and project leads to provide technical and operational support throughout the start-up phase of our new facility.
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Key Responsibilities
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* Ensure all activities are conducted in compliance with HSE and GMP requirements.
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* Work closely with leadership to coordinate resources and support activities throughout the start-up phase.
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* Escalate issues to the appropriate management level when necessary.
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* Organize, prioritize, and deliver on start-up initiatives to adhere to project milestones.
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* Establish framework for operations activities.
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* Write procedures to ensure consistent execution of operations activities.
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* Serve as an integrator to ensure well-planned and executed activities in each phase of the start-up.
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* Participate in or lead efforts associated with the Training Quality system to define the overarching training strategy.
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* Design, develop, and implement biotech operations training through multiple waves of new hires and phases of the project.
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* Assist with on-boarding operations staff throughout the duration of the project.
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* Develop business processes associated with planning and scheduling operations activities.
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* Design and generate facility/process procedures and work instructions, electronic Batch Records, Logbooks, various training documentation, and start-up protocols.
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* Liaise with vendors for equipment, services, and consumables to ensure qualification for the various phases of the project execution.
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* Support protocol executions throughout all phases of the project.
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Requirements
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To be successful in this role, you will need:
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* A minimum of 3 years of biotech manufacturing-related experience, preferably with biosynthetic, fermentation, and/or purification operations experience.
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* Demonstrated skills in project management and coordination.
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* Ability to communicate effectively to various audiences.
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* Ability to influence and network with multiple levels and functions of the organization.
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* Proficient in MS Office applications and training database administration.
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* Familiarity with cGMPs and corporate policies and procedures.
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* Strong written and verbal communication skills.
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* Strong organizational skills – ability to handle/prioritize multiple projects and requests.
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* Able to manage linked activities with rapid flow of integrated information.
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* Strong sense of customer focus and teamwork.
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* Ability to work independently and without direct supervision.
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Preferred Qualifications
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The following qualifications would be beneficial:
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* Language: English
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* Familiarity or expertise in SAP
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* Biotech Operations Experience
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* GMP Operations Experience
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Education Requirements
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You must hold a Third Level Qualification or equivalent education/relevant experience.
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About Us
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We are a global healthcare leader dedicated to improving lives around the world. Our employees work together to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.
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What We Offer
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We offer a dynamic and supportive work environment that values innovation, collaboration, and professional growth.
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Contact Information
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Please do not contact us directly regarding this job posting. If you wish to apply, please follow the instructions provided in the application portal.
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