Serialization BA Validation Tester Biotechnology/Pharmaceutical - PharmEng Technology - Boston, MA

Company Description:
PharmEng Technology is an international full service consulting firm that services pharmaceutical, biotechnology, medical device, nutraceutical, heath care and chemical sectors. PharmEng Technology has a proven track record of excellence which ensures all of client needs and governing regulatory expectations are met and exceeded.

PharmEng Technology provides services in:

-Commissioning & Qualification
- Validation (Manufacturing, Lab)
- Quality systems
- Engineering
- Regulatory Affairs
- Serialization

As a fast pace fast growing consulting firm we are always looking for qualified scientists and engineers with the ability to create and communicate innovative and cost effective solutions to clients. This is a great opportunity to obtain a challenging career that enables you to work closely with major international clients and travel the world!

We currently have projects all over the w orld in Canada, USA, Europe and Asia.

Job Overview:
The role will be part of a global Serialization program team consisting of several individuals responsible for worldwide implementation of Serialization capability at our client’s site. The individual will work closely with the Global Serialization team and internal business and information technology resources to ensure Serialization solution meets regulatory timelines and deliverables.

Responsibilities:
The individual will be responsible for:

  • Assisting in Operational Qualification (OQ) and creating associated documentation
  • Creation of test data and test scripts in support of IQ, OQ, & PQ validation milestones.
  • Assist with testing in Serialization core system and Oracle ERP system.
  • Work with team on technical issues coming from QA testing
  • Work closely with IT Validation Lead to log issues and defects and follow up with developers on fixes.
  • Execution of test scripts, OQ and capturing and preparing the evidence and test documents for review. Work cross-functionally to ensure interdependencies and milestones of local project plan are properly integrated into global program plan
  • Assess current and future impact of test results and relate test outcomes to documentation (SOP’s, Change Requests .etc.)
  • Assisting in the execution of validation strategy and validation master plans
  • Contribute to project URS, FS, DS and validation documents

Capabilities

  • The successful candidate will possess excellent communication skills and will be capable of interacting with all levels within a multi-location organization. The ability to think broadly and facilitate cross-functional test experiences and documentation are key success factors.

Education and Experience:
A minimum of 10 years’ experience working on complex proje cts along with a working knowledge of process validation, software validation, and GMP compliance in the Pharmaceutical or Biotechnology industry is required. A minimum of a Bachelor’s degree or equivalent is required. Supply chain knowledge is required. Serialization knowledge is preferred. Experience with the Axway system is a plus.

Other requirements:
Willingness to travel, Hold a valid driving license and passport, Must be able to legally work in Europe and USA.

Thank you for your interest in our organization. Only those selected will be contacted. No Phone calls please.

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