Manager, Validation Services at LOTTE Biologics

Overview

We are LOTTE Biologics! A new company, built on 80 years of tradition!

We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

We deliver therapies that make a Healthier World!

Responsibilities

To help us meet our mission LOTTE Biologics is in need of a Manager, Validation to coordinate with Manufacturing, Quality, Engineering, and other personnel as needed to manage projects and process improvements. This role will be responsible for planning, managing, and executing enhanced commissioning and validation activities of new equipment, and assist in the creation of validation master/project plans. for, but not limited to: Equipment and Utilities System Qualifications, Requalification, In-Process Equipment, Air Flow Visualization Studies, Temperature Mapping, and Facilities/Utilities Qualifications. This role may lead and/or coach junior team members and contractors during daily qualification activities when required.

• Write protocols, perform field executions, and complete final reports for, but not limited to:
  • equipment/utilities/facilities system qualifications
  • temperature mapping studies
  • utility sampling
  • steaming of process equipment and autoclaves
• Investigate process and quality problems and implement corrective actions
• Identify and define project and process improvement opportunities and support process improvement projects
• Develop project plans and timelines
• Track project schedules and milestones
• Work within cross functional teams
• Communicate progress effectively
• Ensure process and project documentation is accurate and updated
• Maintain safe working environment
• Follow company policies and procedures
• Operate equipment to perform operational qualifications and thermal mapping.
• Record/review data using good documentation practices.
• Conduct investigations as required.
• Support Validation Services activities by writing and revising SOPs, training materials and change requests.
• As a Validation Subject Mater Expert (SME) participate in both regulatory and internal inspections and ensures the timely correction of any outstanding items as a result of inspections.
• The individual maintains familiarity with LOTTE directives and industry guidelines on validation.
• Evaluate and assess change controls request and make recommendation following validation services SOPs.
• Serve as Validation Services designee as directed when training and qualifications are appropriate.
• Support validation department activities to maintain proper documentation storage and database system.

Remote Position

Min Compensation

Max Compensation

Bonus

Qualifications

Education/Experience/ Licenses/Certifications:

BS degree in Engineering, Chemistry, or the Biological Sciences relevant experience or an AS degree with direct validation experience and biopharmaceutical/pharmaceutical experience

Specific Knowledge, Skills, Abilities, etc:

• Direct experience or close familiarity with equipment/utility/facility qualifications and general validation practices is desired.
• A working understanding of lean principles is a plus.
• Excellent project management, communication, and technical writing skills are required. 
• Possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.

Physical Demands:

This position is a primarily an office-based position, however, requires routine entry into laboratories to access instrumentation which requires appropriate levels of personal protective equipment (PPE).  Frequent repeated motions such as lifting, bending, twisting, squatting, walking, and reaching is required. This role also requires occasional unassisted lifting (not to exceed 50 lbs).  Office-based work requires sitting.  Repetitive use of arms/hands/wrists, especially when working with a computer. 

Work Environment:

This position is based indoors in an office environment or laboratory setting, and will be primarily working with others, however, will also work independently and alone at times.  Walking within and between buildings is required to enter laboratories and collaborate with others.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities.  If this is the work that you want to do in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today! 

Company Website

http://www.lottebiologics.com/

Company Profile

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea. LOTTE BIOLOGICS entered the biologics CDMO business after acquiring Bristol Myers Squibb’s Syracuse biologics drug substance manufacturing site, as of January 1, 2023!

The newly established organization aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.  With initial operations in 1948 in Japan, LOTTE has grown to become the fifth-largest conglomerate corporation in South Korea. LOTTE has various business units, including petro/fine chemicals, food, retail, hotels, electronics, construction, and IT. LOTTE has 30 global locations across the US, Europe, and Asia.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.