Associate Engineer/Scientist, Validation 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 an Associate Engineer/Scientist, Validation to support validation activities and ensure protocols and reports are in compliance with company requirements. This position will be responsible for coordinating and managing installation, operational and performance qualification (IQ/OQ/PQ) activities when required.

• Write protocols, perform field executions, and create final reports for:
  • Equipment/utilities/facilities system qualifications.
  • Temperature mapping studies for controlled temperature units (CTUs), warehouse, autoclaves and steaming of process equipment.
• Ensure calibration of equipment used for validation activities is up to date
• Support execution of additional studies such as, mixing validation, air flow visualization studies
• Coordinate and communicate with area owners to ensure completion of requalification and qualification activities.
• Perform requalification/revalidation activities; among the activities required are the following, but not limited to:
  • Prepare equipment to execute protocols.
  • Record/review data using good documentation practices.
  • Obtain samples and submit to the appropriate testing laboratory when required.
  • Notify management of any discrepancy and conduct investigation as required.
• Provide input to Validation Services department SOPs review activities.
• Support validation department activities to maintain proper documentation storage and database system
• Communicate progress effectively
• Ensure process and project documentation is accurate and updated
• Maintain safe working environment
• Follow company policies and procedures
• Engage in, and contribute to continuous improvement projects

Remote Position
No
Min Compensation
USD $60,000.00/Yr.
Max Compensation
USD $88,000.00/Yr.
Bonus
8%
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 validation is desired. Excellent communication and technical writing skills are required.
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.
Work Location:
East Syracuse
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.