Job Description Position Overview: The Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of F&E and client site manufacturing facilities.
This role involves providing crucial support in various areas including documentation changes, pest control program management support, deviations and Corrective and Preventive Actions (CAPAs), and Change Controls.
Key Responsibilities: 1.
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.
2.
Pest Control Program: • Provide support to the pest control program to maintain a pest-free environment within the facility.
• 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.
3.
Deviations and CAPAs: • Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures(SOPs).
• Work closely with the Quality team to initiate and implement effective Corrective and Preventive Actions (CAPAs).
• Monitor and track the progress of Deviations and CAPAs, ensuring timely closure and compliance.
4.
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.
Qualifications: • Bachelor's degree in Engineering, Life Sciences, or a related field.
• Strong understanding of documentation control, pest control programs, deviations/CAPA management, and Change Controls.
• Knowledge of regulatory requirements, including FDA and other relevant authorities.
• Excellent organizational, communication, and problem-solving skills.
• Detail-oriented with a focus on quality and compliance.
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 Shift: First shift | M-F Requirements Position Overview: The Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of F&E and client site manufacturing facilities.
This role involves providing crucial support in various areas including documentation changes, pest control program management support, deviations and Corrective and Preventive Actions (CAPAs), and Change Controls.
Key Responsibilities: 1.
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.
2.
Pest Control Program: • Provide support to the pest control program to maintain a pest-free environment within the facility.
• 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.
3.
Deviations and CAPAs: • Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures(SOPs).
• Work closely with the Quality team to initiate and implement effective Corrective and Preventive Actions (CAPAs).
• Monitor and track the progress of Deviations and CAPAs, ensuring timely closure and compliance.
4.
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.
Qualifications: • Bachelor's degree in Engineering, Life Sciences, or a related field.
• Strong understanding of documentation control, pest control programs, deviations/CAPA management, and Change Controls.
• Knowledge of regulatory requirements, including FDA and other relevant authorities.
• Excellent organizational, communication, and problem-solving skills.
• Detail-oriented with a focus on quality and compliance.
