Position Brand Description:
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 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. This position is part of the Contamination Control team.
Key Objectives/Deliverables:
Manage for Results /Strategic Planning:
- Develops and executes qualification and validation documents, including protocols and reports, product stage determination documents and cleaning execution plans.
- Reviews protocols and technical reports, both within and external to Technical Operations.
- Performs cleaning validation/verification sampling, small-scale studies, and submits samples for analysis.
- Performs hold studies to support qualified manufacturing hold time for process buffers.
- Schedule and coordinate cleaning and changeover activities with Manufacturing areas.
- Maintains the validated state of process equipment through cleaning monitoring and trending of cleaning cycles.
- Participates/facilitates in design reviews to ensure design meets user requirements.
- Develops and/or updates validation SOPs and Policies,
- Prioritizes validation activities. Communicates and documents status to management and appropriate departments.
- Uses effective project management skills to manage multiple activities and ensure on-time project delivery.
- Provides technical evaluations of complex validation issues supporting discrepancy / deviation investigations and develops corrective action plans, as required.
- Evaluates changes to the validated state of systems through change control procedures and participates in the planning and implementation of changes.
- Represents department as subject matter expert (SME) presenting validation activities during regulatory inspections.
Manage Relationships with Key Stakeholders and Customers:
1. Participate in Process Flow Teams as needed.
Basic Requirements:
- Position is a banded position; education and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered for initial placement within the band.
- Ability to work with others in a fast-paced environment.
- 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.).
- Understanding of key Data Integrity principles (ALCOA+) to ensure requirements are aligned to appropriate testing strategies.
Additional Preferences:
- Knowledge of validation lifecycle approach and FDA/international regulatory requirements.
- Knowledge of contamination control strategies.
- Experience with the following applications/systems is a plus: TrackWise, KNEAT, LIMS.
Education Requirements:
1. Bachelor’s degree in engineering, Science, or related discipline.
Other Information:
1. Travel not required.
2. Lifting required (NMT 50 lbs.)
3. Occasional off hours work to accommodate manufacturing schedule.
4. On a non-routine basis, confined space entry and tank entry with the use of a harness may be required.
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, and 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.
