Job Title: Validation/Quality Engineer
Company: Assure Infusions, Inc.
Company Description: Assure Infusions is a manufacturer of sterile IV fluids.
Job Summary:
Assure Infusions, Inc. is seeking a meticulous Validation/Quality Engineer to join our team. The Validation Engineer will be responsible for ensuring that all equipment and processes meet regulatory requirements and industry standards to maintain the quality and safety of our sterile IV fluid manufacturing operations.
Duties:
- Develop and execute validation protocols for equipment, processes, and systems in compliance with regulatory guidelines.
- Perform validation testing, data analysis, and documentation for new equipment installations and process improvements.
- Collaborate with cross-functional teams to troubleshoot validation issues and implement corrective actions.
- Conduct risk assessments and validation studies to ensure product quality and regulatory compliance.
- Provide technical support for validation activities during audits and inspections.
Experience:
- Experience in cGMP and Qulity managment system
- Proficiency in weld programming and familiarity with industrial equipment.
- Experience in project scheduling and working with CNC machines.
- Knowledge of Quantum engineering principles and mechanical systems.
- Must have hands on experience in developing, executing and generating validation reports for pharmaceutical manufacturing and laboratory equipment
Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required
Skills:
- Strong attention to detail and analytical skills.
- Excellent communication and teamwork abilities.
- Ability to work independently and prioritize tasks effectively.
- Problem-solving skills with a proactive approach to challenges.
Benefits:
- Competitive salary commensurate with experience.
- Health insurance benefits package.
- Opportunities for professional development and growth within the company.
If you are a dedicated Validation Engineer with a passion for ensuring product quality in a manufacturing environment, we encourage you to apply. Join Assure Infusions, Inc. where your expertise will contribute to the production of life-saving IV fluids.
Job Type: Full-time
Pay: $66,866.70 - $80,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Flexible schedule
- Health insurance
- Paid time off
Experience level:
Schedule:
Work setting:
- In-person
- Manufacturing facility
Ability to Commute:
- Bartow, FL 33830 (Required)
Ability to Relocate:
- Bartow, FL 33830: Relocate before starting work (Required)
Work Location: In person