Validation Specialist III
Discovery Drive, SWDD Swiftwater, PA
The candidate will be a member of the Viral Technology team responsible for experimental execution within pilot plant and production areas. The candidate for this position will need to become trained on applicable production operations on the unit operations in the lab as well as general laboratory procedures. Following training, the candidate will be expected to independently execute assigned experiments with minimal direction from laboratory supervision.
Key responsibilities include:
- Responsible for authoring and reviewing development and validation notebook studies/ protocols/ reports
- Execution of studies in piolet plant / manufacturing environment
- Follow good documentation practices to record all activities performed and data generated in production of developmental experiments
- Follows all procedures put into effect to ensure your safety as well as the safety of others. Participates in safety meetings, reports all safety issues, concerns, incidents and near misses to the team leadership.
- Identifies production issues and relays them to the laboratory management. Ensures all required paperwork is complete, accurate and done in a timely manner to ensure a quality product.
- Participation in cross-functional teams, where necessary, to assure correct performance of process operations and working with management to resolve process operations issues.
- MS Office
- EDoc, with a working knowledge of templates, workflows and approval process
- LabWare/ LIMS experience preferred
- Full understanding of GMP Documentation and current GMP standards
- Good lab / aseptic technique
- To be able to establish professional working relationships with other support and production areas in order to gather all of the necessary information required.
- Interact well and professionally with a diverse group of individuals
- Self-motivated and willing to be proactive in resolving issues
- Excellent Verbal and written communication skills.
- Ability to work in a team environment
- Ability to write and complete deviations in a timely and thorough manner
- Ability to multitask and prioritize tasks
- Flexibility of hours during execution to include nights and weekends
Bachelor’ s degree in scientific discipline plus 3-6 years of experience in Vaccine, Biologic, or Pharmaceutical manufacturing and/or development.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.