Position: Validation Specialist III (Engineering), Req#: SNFIJP00002447
Location: Swiftwater, PA
Duration: 6+ Months contract
- This position is for a well-rounded scientist that will do both document writing and lab work. Document writing is a priority but we need to generate the data first, so I would say it will be 50-50 between lab and desk work.
- We need an energetic and flexible individual that will be able to quickly switch between the lab, shop-floor, and document generation. It is a high priority/high-intensity project and they will also assist with quality approved data packs, validation activities- deviations, etc. So, experience in a GMP environment is also a plus.
- Chromatography and TFF are the two main unit ops that they will need to know or learn for this process.
The candidate will be a member of the Bacterial Technology team responsible for experimental execution within the 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.
Education and Experience:
- Bachelor’s degree in scientific discipline plus 3-6 years of experience in Vaccine, Biologic, or Pharmaceutical manufacturing and/or development
- Knowledge of equipment qualification process
- Experience in process validation (PPQ), validation execution in a production environment.
- MS Office
- Geode, with a working knowledge of templates, workflows and approval process
- LabWare/ LIMS experience preferred
- Full understanding of GMP Documentation and current GMP standards
- 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
- The flexibility of hours during execution to include nights and weekends
- Responsible for authoring and reviewing development and validation notebook studies/ protocols/ reports/ compiling data packs.
- Create and support Change Control documentation for validation and equipment changes.
- Execution of studies in pilot plant/manufacturing environment
- Follow good documentation practices to record all activities performed and data generated in the 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 leader.
- 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.