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We are seeking a Facilities and Engineering Support Specialist to maintaining the integrity and compliance of the manufacturing facility. This role involves providing crucial support in Quality Systems, including deviations, Corrective and Preventive Actions (CAPAs), Change Controls, documentation changes, pest control program management support, and OEFM electronic forms.
Key Responsibilities:
1. Quality Systems:
- Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
- Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
- Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
- Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
2. Documentation Changes:
- Facilitate and manage documentation changes related to facilities and engineering processes.
- Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
- Collaborate with relevant stakeholders to implement documentation changes efficiently.
3. OEFM Electronic Forms:
- Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms.
- Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines.
- Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues.
4. Pest Control Program:
- Support the transformation of the Pest Control program into a state of the art program.
- Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
- Support the documentation and records related to the pest control program.
5. Change Controls:
- Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
- Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
- Maintain Change Control records and provide support during regulatory inspections.
Requirements
- Education: Doctorate degree and 2 years of Engineering experience or, Master’s degree and 6 years of Engineering experience or Bachelor’s degree and 8 years of directly related experience
- Strong knowledge and demonstrated experience with Quality Systems, particularly deviations, CAPA management, Change Controls, and controlled documentation.
- Some Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems preferred.
- Some understanding of pest control programs within a regulated manufacturing environment.
- Knowledge of regulatory requirements, including FDA and other relevant authorities.
- Excellent organizational, communication, and problem-solving skills.
- Detail-oriented with a focus on quality, compliance, and timely execution.
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