Process Specialist

Process Specialist

Requirements

• Degree in Microbiology, Virology, Immunology, Biological Systems Engineering, Mechanical Engineering, Packaging Engineering, Chemical Engineering or related technical field.
• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent interpersonal skills and ability to interact across divisional boundaries.
• Must have strong technical writing skills.
• Must possess a high degree of personal motivation.
• Must be capable of communicating (both written and verbally) with colleagues at all levels in the business.
• Strong technical/analytical/problem solving skills and experience.

Responsibilities

• Conduct and author process investigations and reports, utilizing Right First Time (RFT) tools and scientific reasoning.
• Ensure corrective actions are identified and implemented to eliminate the root cause of the problem, partner with other Zoetis colleagues within the network when needed.
• Examine processes and review data, to identify best practices and take action to reduce contamination, increase efficiencies and increase potencies.
• Take the manufacturing lead in continuous improvement efforts. Be proficient in leading change, writing change control documents and managing /coordinating all aspects of project implementation.
• Take the manufacturing lead in the introduction of new processes or modifications to existing processes as supported by Global Manufacturing Technology (GMT). Assist in performing technical evaluations and implementation of GMT initiatives to ensure robust process improvements and transfers.
• Provide technical and biological expertise to Process Team process improvement discussions (e.g., as part of Gemba walks) to improve process reliability, robustness, cost, and efficiency.
• Review production data in order to identify opportunities for yield improvement, collaborating with the Production Controller.
• Responsible for identifying and implementing delivering Cost Improvement Projects (CIP).
• Collaborate with QA and Regulatory to Review manufacturing directions and associated documents (this includes reviewing OOPs, Dossiers, PMs, SOPs and representation at Change Control and Dport).
• Communicate and work with the Equipment Engineer and/or Maintenance on process improvements of equipment and new projects.
• Collaborate with area Team Leader and cell leads to train and lead colleagues in the performance of best practices.

Preferred Qualifications

• Preferred experience in biological production systems, biological product formulations (blend/fill/lyophilization), and/or biological testing.
• A working knowledge of vaccine production methods and experimental design and experience in GLP or cGMP.
• Knowledge of APHIS, VMD, USDA regulations applicable to the Pharmaceutical/Biological industry is preferred.
• Preferred experience in Lean/Six Sigma. Green Belt certification if currently doesn’t have Green belt certification, commitment to obtain green belt certification within 1 year of training, which may require limited travel.