Senior Specialist, Validation Services

Job Description

We are LOTTE BIOLOGICS! Delivering Therapies That Enable a Healthier World.

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.

Position Summary

As a Senior Specialist, Validation Services, you will play a key role in supporting and leading validation activities, ensuring protocols and reports meet LOTTE BIOLOGICS standards. Reporting to the Senior Manager, Validation Services, you will manage and coordinate installation, operational, and performance qualification (IQ/OQ/PQ) efforts as needed. This is a great opportunity to make a meaningful impact while working in a collaborative, quality-driven environment.

Duties & Responsibilities

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

Education & Experience

Bachelor's degree in Engineering, Chemistry, Biological Sciences, or a related field; or an Associate's degree with relevant direct validation experience in the biopharmaceutical or pharmaceutical industry.

Prior experience in validation activities or strong familiarity with validation processes is highly preferred.

Knowledge, Skills, Abilities

Excellent communication and technical writing skills are required.

Strong understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Ability to interpret and apply validation protocols, test plans, and regulatory guidelines.

Proficiency in troubleshooting equipment and systems during validation activities.

Ability to manage multiple assignments and prioritize tasks in a fast-paced environment.

Detail-oriented with strong analytical and problem-solving skills.

Proficient in using Microsoft Office applications (Word, Excel, Outlook) and validation database systems.

Ability to work collaboratively with cross-functional teams (e.g., manufacturing, quality, engineering).

Knowledge of environmental monitoring practices and controlled temperature unit (CTU) operations.

Ability to perform data review and trend analysis to support validation conclusions.

Familiarity with laboratory sample handling and chain of custody requirements.

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.

Travel

<5% travel may be required for this role.

Target Bonus

8%

Work Location

East Syracuse, NY

New York Pay Range

$28.85—$42.31 USD

We are an Equal Employment Opportunity ("EEO") Employer.

Full-time