Equipment Engineer

Equipment Engineer

The Equipment Engineer evaluates, inspects, maintains, designs, analyzes and improves equipment used in all aspects of processing at CTS. Executes validation protocols for equipment to assure compliance with regulatory standards.  Offers technical support to all departments, including tissue branches, for equipment-related issues. Writes standard operating procedures, and defines necessary quality control and calibration parameters.

Essential Functions                                                    

1. Acts as the Subject Matter Expert (SME) for equipment and centralized monitoring system used by Community Tissue Services (CTS) and its branches.
2. Explores and implements new equipment/materials/systems for the purpose of process improvement initiatives.
3. Collaborates with manufacturing, CTS branches and support departments on resolving issues/problems that prevent process improvement.
4. Develops and executes validation and compliance activities on equipment/computer system qualification projects according to all regulations.
1. Assists Validation Manager with Master Validation Plans as needed.
5. Ensures seamless equipment implementations by assisting in planning, training, and communications with related functional areas.
6. Develops/revises standard operating procedures (SOPs) for new and existing equipment.
7. Evaluates deviations to determine impact to products or processes and develops appropriate actions to achieve an acceptable resolution.
8. Oversees and maintains documentation on equipment validations, all Quality Controls, calibrations and troubleshooting procedures for reference and regulatory purposes.
9. Performs other duties and serves as equipment SME on projects as assigned.

Education and/or Experience

• Bachelor's degree.
• Minimum two years of experience in a regulated industry, including experience in equipment validation.

Work Environment and Physical Activities

• Requires heavy lifting. 
• Must be able to meet the required physical demands with or without reasonable accommodation.

• Bachelor’s degree in Medical Technology, Biology, Life Sciences, Biomedical Engineering, or equivalent preferred.
• Demonstrated ability to work independently and within a team, with minimal oversight.
• Demonstrated ability of strong critical thinking, analytical, and problem-solving skills.
• Certified Tissue Bank Specialist (CTBS) certification.
• Technical and professional experience in analyzing process opportunities and developing and implementing strategies for improvement.
• Proven ability to inspire individuals and develop functional teams that commit to collectively working towards the achievement of corporate objections.
• Knowledge of applicable regulatory requirements from AABB, AATB, FDA, OSHA & ISO.
• Experience in auditing, quality control, quality assurance, clinical laboratory, blood/tissue banking, or pharmaceutical/other manufacturing environments.
• Sound knowledge and understanding of GMP requirements and industry standards. 
• Periodic travel may be required.

We Offer: