$50K - $60K/yr
Full-time
Posted 25 days ago
Job description
About Medivant Healthcare
Medivant Healthcare is a U.S.-based pharmaceutical manufacturer specializing in sterile injectable generics for hospitals, clinics, and healthcare providers nationwide. Our FDA-registered facilities in Chandler and Deer Valley, Arizona, are dedicated to ensuring consistent product quality, regulatory compliance, and affordable medication access.
Position Summary
The Validation Engineer and CQV Associate supports validation documentation, data collection, and quality system activities in Medivant’s sterile injectable facility. This entry-level role is ideal for recent graduates seeking hands-on cGMP and aseptic processing experience.
Key Responsibilities
• Assist in execution of media fill studies and documentation.
• Support area qualification and environmental monitoring tasks.
• Help draft IQ/OQ/PQ protocols and assist execution.
• Collect data for HVAC, WFI, and compressed air validation.
• Assist in cleaning validation logs and sample documentation.
• Participate in process validation protocol preparation.
• Support change control documentation.
• Assist in deviation data collection and preliminary reports.
• Track CAPA activities and closure evidence.
• Ensure cGMP compliance in all assigned tasks.
Qualifications
Required:
• Bachelor’s degree in Pharmacy, Biotechnology, Microbiology, Life Sciences, or related field.
• 2-3 years of relevant experience is required
• Understanding of aseptic and sterile processing.
• Strong documentation and communication skills.
Preferred:
• Experience in sterile manufacturing or validation support.
• Knowledge of QMS processes and cGMP environments.
Employment Details
• Full-time onsite role at Medivant Healthcare facilities.
• Standard work schedule: Monday–Friday.
• Training provided for all validation and QMS procedures.
Please note that we are not providing H1B visa sponsorship for this role. Candidates will be solely responsible for managing and maintaining their own visa sponsorship status.
Frequently asked questions
Q: What skills or qualities help someone succeed as a Validation Engineer?
A: To succeed as a Validation Engineer, key technical skills include proficiency in regulatory frameworks such as FDA and ISO 13485, as well as expertise in validation methodologies like risk-based validation and design control. Additionally, strong analytical and problem-solving skills, along with proficiency in programming languages like Python or SQL, are essential for developing and executing validation protocols. Soft skills such as effective communication, attention to detail, and a methodical approach to problem-solving also contribute to success in this role, enabling Validation Engineers to collaborate with cross-functional teams and ensure compliance with regulatory requirements.
Q: What is the career path for a Validation Engineer?
A: A Validation Engineer's career path typically begins with entry-level roles such as Validation Engineer or Junior Validation Specialist, where they gain hands-on experience in designing, implementing, and executing validation protocols for medical devices, pharmaceuticals, or other regulated products. As they progress to mid-level roles like Senior Validation Engineer or Validation Lead, they develop expertise in regulatory compliance, risk management, and team leadership, and may also take on responsibilities such as training and mentoring junior engineers. Senior Validation Engineers or Validation Managers often oversee large-scale validation projects, develop and implement validation strategies, and may also pursue certifications like CQE (Certified Quality Engineer) or CVA (Certified Validation Engineer) to further advance their careers.
