What are the responsibilities and job description for the Validation Engineer position at Celltrion Branchburg, LLC?
Position Summary:
This position requires knowledge of cGMPs, excellent technical writing, and problem-solving skills. Responsibilities will include, but not limited to, development and execution of installation, operational, and performance qualification protocols/test cases and reports, ensuring qualification and validation activities meet internal and external compliance requirements, effectively manage projects to deliver on time and consistent results, and coordinating validation activities with the appropriate functional groups.
Key Objectives/Deliverables:
Manage for Results /Strategic Planning:
- Develop and execute qualification and validation documents using a risk-based approach for biopharmaceutical manufacturing equipment and supporting systems.
- Participate/facilitate user requirements development and design reviews to ensure design meets user requirements.
- Develop and/or update validation SOPs and Policies as needed.
- Prioritize validation activities. Communicate and document status to management and appropriate departments.
- Use effective project management skills to manage multiple activities and ensure on-time project delivery.
- Provide technical evaluations of complex validation issues supporting discrepancy/deviation investigations and develop corrective action plans, as required.
- Operate and maintain data acquisition systems and validation testing instruments used for temperature mapping including Kaye Validator and wireless data loggers.
- Maintain the validated state of assets through periodic monitoring.
- Evaluate changes to the validated state of systems through change control procedures and participate in the planning and implementation of changes.
- Represent department as subject matter expert (SME) presenting validation activities during regulatory inspections.
- Understanding of key Data Integrity principles (ALCOA ) to ensure requirements are aligned to appropriate testing strategies.
- Participate in Process Flow Teams as needed.
Basic Requirements:
- Minimum of 0 years to 5 years experience in qualification/validation of typical GMP utilities, facilities, computer systems and/or process equipment in a pharmaceutical/ biopharmaceutical facility.
- Bachelor’s degree in Engineering, Computer Science, Science, or related discipline.
- Knowledge of validation lifecycle approach and FDA/international regulatory requirements.
- Ability to work with others in a fast-paced environment.
- Must have strong communication skills, both oral and written, to effectively communicate technical information in a clear and concise manner within a GMP environment.
- Strong analytical, problem solving, and excellent interpersonal skills.
- Proficient in MS Office (Word, Excel, Project, Outlook, etc.).
- Experience with the following applications/systems is a plus: TrackWise, Maximo, LIMS.
This role is exempt and the anticipated compensation for this role is $72,000 - $116,000
This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.
Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, the ability to lift 50 pounds may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.
Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.
Salary : $72,000 - $116,000