Strides Pharma, Inc, is a worldwide pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world's largest manufacturers of soft gelatin capsules.
We are currently hiring a Packaging Engineer for our new Riviera Beach, FL facility. This is our first pharmaceutical manufacturing facility in the USA and expect extensive growth over the next couple of years.
This position is responsible for package engineering and packaging validation activities for soft gel capsules. Responsibilities include participation in cross-functional teams or leading cross-functional team for validation, leading cost improvement projects in packaging and leading relevant packaging changes.
• Leading package engineering projects in packaging facilities area for soft gel capsule. The focus is on primary package design through identification of selecting and recommending solutions
• Conduct & evaluate complex packaging design & development to test, prove or modify new package components for new products
• Manage package qualification testing, packaging equipment performance qualification and packaging validation per site procedures
• Support & troubleshoot commercial packaging operations, support process optimization teams with broad knowledge of process and cleaning needs
• Author, execute and close out qualification and or validation documents, gap/risk assessment and relevant VMP
• Write SOPs that clearly represent the proper production activities and techniques to reproduce products that meet intermediate and final product specifications for quality, purity, performance and safety
• Knowledge of current and advanced validation strategies, current regulatory landscape and agency expectations for pre-validation, PPQ and CPV including validation of soft gel capsule forms using novel manufacturing technologies
• A BS in Packaging Engineering, Pharmaceutical Engineering, Pharmaceutical Manufacturing, or Pharmaceutical Technology is required. Masters preferred.
• Proficiency with statistics and project management tools is required
• Experience using Excel for data mining and analysis is required
• Minimum experience of 5 years in qualification and or validation of packaging processes including risk management (preferably for soft gels)
- Project Management: 5 years (Required)
- Documentation: 5 years (Required)
- Packaging Serialization: 5 years (Required)
- CAPA: 5 years (Required)
- Change Control: 5 years (Required)
- New Product Introduction: 5 years (Required)
- Project Management Skills is a plus
- Demonstrated Packaging Serialization Knowledge
- Experience in creating Packaging Serialization Systems
- New Product Introduction Experience
- Trackwise Expertise
- Working knowledge of pharmaceutical processes
- Familiarity with validation processes
- Familiarity with documentation in a highly regulated environment
- Ability to interpret and apply GLPs and GMPs
- Ability to apply engineering science to production
- Able to develop solutions to routine technical problems of limited scope
- Demonstrated skills in the following areas:
- Problem solving and applied engineering.
- Basic technical report writing
- Verbal communication
- Comprehensive understanding of validation protocol execution requirements
We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas currently.
Strides Pharma, Inc, Inc. uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
Strides Pharma is an Equal Opportunity Employer