Process Specialist

Charles City

Full time

JR00013000

Job Description:

Provide the first line of response to address and support manufacturing deviations and investigations. All investigations and process changes are documented and managed within Trackwise, Event Tracking System. Take manufacturing lead in implementation of changes and improvement action items as a fall out of investigations. Support process and product transfers developed by Global Manufacturing Technology (GMT) organization such as new product transfers and continuous process improvements. Conduct activities and make decisions that are in accordance with Company policies & SOPs, Zoetis Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.

 

Position 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 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.

 

Education and Experience:

  • Specialist Level: BA/BS with 2-4 years of experience OR MBA/MS with 0-2 years of experience OR 8 years relevant experience.   Associate Level: BA/BS with 0-2 years of experience OR 6 years relevant experience.

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.

 

Technical Skills Requirements

  • 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.
  • Excellent interpersonal skills and ability to interact across divisional boundaries.
  • 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.
  • Demonstrated ability to lead investigations by performing technical evaluation followed by implementation of change initiatives to ensure robust process improvements.
  • 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.

 

Physical Requirements

  • Must be able to walk or stand for long periods of time.
  • Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
  • Must be able to work scheduled 40 hours with the ability to work overtime as needed.
  • Frequent lifting and carrying of 5 to 25 lbs.
  • Regular reaching, bending, stooping, and twisting
  • Repetitive motion and substantial movement of the wrists, hands, and/or fingers
  • Able to become qualified to enter clean room environments
  • Work Environment: While performing the duties of this job, the employee occasionally works in environments with extreme temperature (hot /cold) & humidity, with limited lighting and in crowded spaces.  The noise of these work environments are typical office noises.