The Role
Supports facilities and engineering quality systems in a regulated manufacturing environment. Responsibilities include managing deviations, CAPAs, change controls, documentation updates, OEFM electronic forms, and inspection-ready records. The role also supports pest control program improvements, vendor coordination, regulatory compliance, and evaluation of changes to facilities, utilities, equipment, and critical utilities.
Summary Generated by Built In
• 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.
Position Overview: The Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of F&E and site manufacturing facilities. 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:
o Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
o Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
o Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
o Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
2. Documentation Changes:
o Facilitate and manage documentation changes related to facilities and engineering processes.
o Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
o Collaborate with relevant stakeholders to implement documentation changes efficiently.
3. OEFM Electronic Forms:
o Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms.
o Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines.
o Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues.
4. Pest Control Program:
o Support the transformation of the Pest Control program into a state of the art program.
o Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
o Support the documentation and records related to the pest control program.
5. Change Controls:
o Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
o Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
o Maintain Change Control records and provide support during regulatory inspections.
Requirements
- 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
First shift
Skills Required
- Doctorate degree and 2 years of engineering experience
- Master's degree and 6 years of engineering experience
- Bachelor's degree and 8 years of directly related experience
- Strong knowledge and demonstrated experience with quality systems, including deviations, CAPA management, change controls, and controlled documentation
- Knowledge of regulatory requirements, including FDA and other relevant authorities
- Experience supporting OEFM electronic forms or similar electronic quality and facilities-management systems
- Understanding of pest control programs within a regulated manufacturing environment
- Excellent organizational, communication, and problem-solving skills
- Detail-oriented approach focused on quality, compliance, and timely execution
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The Company
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
