Validation Specialist III — 317136 : MTech Project Costs-Contractors 3000 (19-00848) – PA – Swiftwater

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 or Geode, 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
Source: Job Diva – Job Listing

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