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Validation Specialist

Allentown-Bethlehem-Easton Metro Area, Pennsylvania

Post Date: 04/10/2017 Job ID: JN -042017-18800 Industry: Regulatory - Scientific
Description:

Duties:
Our Bacterial Technology group has two(2) openings 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.

Skills:
- 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

Education:
2 to 5 years. Experience in writing protocols/reports for one or more of the following:
1. Cleaning Validation,
2. Process Validation,
3. Filter Validation
4. Leachable/Extractable Validation
2-5 years hands on Laboratory Experience in Fermentation a must and include the following:
1. Fermentation Operations
2. Fermentation Cleaning
3. Waste Disposal

BS in Life Sciences, Biochemistry or Chemical/biochemical Engineering Required

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