Medical Package Testing (MPT) Manager

Company

Life Science Outsourcing, Inc.

(www.lso-inc.com) is in North Orange County in the city of Brea, California. Life Science Outsourcing, Inc (“LSO”) is a contract manufacturer of medical devices with in-built capabilities to offer clients full-service solutions through our six divisions. Clients rely on LSO to perform all activities required to introduce their products to market, from sourcing to drop shipping. We are shaped by our values: Do the Right Thing, Customer Success, Employee Success, Speed and Simplicity.

In January 2021, LSO partnered with PPC Enterprises (www.ppcenterprises.com), a leading private equity firm based out of New York, to expand LSO’s geographic reach in the medical device arena.

We are currently seeking an energetic and motivated Medical Package Testing (MPT) Manager to join our fast-growing organization. In this role, you will be responsible for sales and business unit leadership alongside executive management of the Medical Package Testing Department reporting to the CEO.

And no matter where you look at LSO, you will witness our shared purpose—helping realize life’s potential—in action; it’s at the heart of what we do. Our work helps improve millions of lives. We hope you will see yourself here, too.

We encourage you to submit a resume with salary requirements.

Job Description

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Responsible for applying engineering principles to implement the accurate design, qualification and implementation of medical package testing associated systems such as documentation, equipment and processes.
• Actively build upon client relationship efforts to market and cross-sell the various services provided by LSO.
• Maintain a working knowledge of business process optimization, financial reporting/management reporting, ERP implementations, and FP&A Analytics appropriate for the department.
• Manage the execution of engagements focusing on operating enhancements, shared services, and strategy.
• Serve in more of a leadership role on client work as technical knowledge and experience grows.
• Primary contact for customer interfacing, quotations and protocols.
• Innovate: Evaluate and screen new technologies and/or packaging solutions based on market trends product, regulatory, business or technical requirements.
• Maintains a professional working relationship with internal and external customers and support staff.
• Implement validation studies on specified customer equipment / process to ensure consistency of data production and concurrence with manufacturer and FDA/ISO standards.
• Manage and supervise all aging activities having to do with Real Time aging, Accelerated aging, and package testing.
• Oversees validation of customer specified processes, performs statistical analysis, develops validation models, and writes process validation protocols and final packages.
• Responsible to oversee and manage facility equipment, installation, maintenance, repairs, physical structures, pipe, and electrical system.
• Serves as Package testing liaison with QA, Regulatory Affairs, Research and Development and all departments.
• Supervises routine testing for product release and stability studies related to package validation protocols.
• Assigns tasks to appropriate personnel related to the completion of validation protocols and/or test requests.

Qualifications

• MBA and 4 years of experience in overseeing the operations of their unit and ensure they are efficient and competitive and/ or;
• Bachelor’s degree and 6 years of engineering/scientific experience
• Entrepreneurial thinker with proven skills working in teams or leading project teams
• Familiar with distribution testing per ASTM D4169. Familiarity with ASTM, ISO 11607-1 & -2, MDD/MDDR TAPPI, USP and EP testing standards.
• Extensive knowledge of documentation management and understanding of Good Manufacturing Practices (GMPs)
• Experience with Packaging Validation of Medical Devices (IQ-OQ-PQ).
• Experience with utilizing ERP/MRP Information systems
• Experience with Lean and Lean Sigma concepts.
• Strong organizational, project management, technical problem solving and communication (written and verbal) skills, and the ability to work in teams and adapt to constantly evolving environment.
• Strong Interpersonal and communication skills