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Validation Specialist III
Ref No.: 17-15938
Location: Swiftwater, Pennsylvania
Job Title: Validation Specialist
Job Location: Swiftwater, PA
Job Duration: 2 Months ( Possible Extension)

Job Description: 

Position requires a mix of Laboratory and Validation experience. Candidates must have experience with lab experience with either fermentation or purification. Although this position is approved only until the end of the year it will likley extend into next year.
Our Bacterial Technology group has an opening for a Laboratory Technician/Validation Specialist position at our Swiftwater site. The positions will required the candidate to function in a laboratory support operator in addition to Validation support activities.
Validation Responsibilities include:
Working closely with subject matter experts (SME) to generate validation documents compliant with the site policies and procedures
Perform validation sampling and data analysis of the results
Ensure proper execution/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
Assist in writing Standard Work Instructions and Batch Production Records
Leachable/Extractable Validation
Laboratory Technician responsibilities include:
Execution of development studies (fermenter cleaning, media preparation, seed expansion, fermenter operation, sampling and analysis, waste disposal) and maintaining thorough records in lab notebooks [80% time]
Assisting with protocols, development reports and datapacks [20% time].
For both responsibilities, flexible schedule with shift work is essential; weekend work may be required. Basic technical writing and communication skills are desirable.

Hands-on biological laboratory operations
- Adherence to safety and cGLP procedures; use of PPE
- Basic writing and communication skills
Proficient in:
MS Office 2010 MS Word, Excel, PowerPoint and Outlook
EDoc with a working knowledge of templates, workflows and approval process
Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Cleaning Validation
Technical writing abilities and time management skills.
Strong root cause analysis skills with cGMP experience.
To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
Interact well with a diverse group of individuals.
Self-motivated and willing to be proactive in resolving issues
Demonstrate the ability to successfully interface with QA personnel.
Excellent Verbal and written communication skills. Ability to work in a team environment.
Leachable/Extractable Validation