Address
Form of workJob Description
DUTIES
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The FSL/Validation Specialist will be responsible:
Perform aseptic validation sampling and data analysis of the results
Ensure proper execution and GMP Documentation of test results, and compilation of validation packages.
Retrieve and compile data from electronic sources / databases and paper records
Responsible for authoring, reviewing, executing and approving validation documents written within an electronic data management system. Execution of Validation Protocols.
Assist in writing and revising Standard Work Instructions , Standard Operating Procedures, and Batch Production Records
SKILLS
Experience:
3-10 years. Experience in working in a Pilot Plant and/or cGMP manufacturing environment. Sample coordination and execution of Validation Protocols are preferred.
Proficient in:
MS Office 2010 MS Word, Excel, PowerPoint and Outlook
EDoc with a working knowledge of templates, workflows and approval process
Utilize cGMP skills and methods either in a manufacturing or Pilot Plant environment
Good lab / aseptic technique
Knowledge of current GMP Standards
Experience in LIMS preferred
Full understanding of GMP Documentation
Flexibility of hours during execution to include nights and weekends
Cleaning validation execution preferred. Experience with Manual and Automated Cleaning Systems
Technical writing abilities and time management skills.
Root cause analysis skills with cGMP experience.
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
Education
BS/MS in Engineering, Life Science or Physical Science
________________________________________
The FSL/Validation Specialist will be responsible:
Perform aseptic validation sampling and data analysis of the results
Ensure proper execution and GMP Documentation of test results, and compilation of validation packages.
Retrieve and compile data from electronic sources / databases and paper records
Responsible for authoring, reviewing, executing and approving validation documents written within an electronic data management system. Execution of Validation Protocols.
Assist in writing and revising Standard Work Instructions , Standard Operating Procedures, and Batch Production Records
SKILLS
Experience:
3-10 years. Experience in working in a Pilot Plant and/or cGMP manufacturing environment. Sample coordination and execution of Validation Protocols are preferred.
Proficient in:
MS Office 2010 MS Word, Excel, PowerPoint and Outlook
EDoc with a working knowledge of templates, workflows and approval process
Utilize cGMP skills and methods either in a manufacturing or Pilot Plant environment
Good lab / aseptic technique
Knowledge of current GMP Standards
Experience in LIMS preferred
Full understanding of GMP Documentation
Flexibility of hours during execution to include nights and weekends
Cleaning validation execution preferred. Experience with Manual and Automated Cleaning Systems
Technical writing abilities and time management skills.
Root cause analysis skills with cGMP experience.
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
Education
BS/MS in Engineering, Life Science or Physical Science
