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Validation Engineer - III (Senior) : Durham, NC

Company:
Lancesoft Inc
Location:
Durham, North Carolina, 27712, United States
Posted:
March 21, 2017
Description:

Responsibilities:

•As part of Global Vaccine Technology organization (GVT), the Validation team within the vaccine manufacturing facility in Durham, NC is seeking a contract Cleaning Validation Engineer

•The Validation team provides technical process and validation support for the manufacture of Bacillus of Calmette and Guerin (BCG) culture based product

•The Cleaning Validation Engineer will partner with Manufacturing Operations, Quality Control, Plant Engineering, and Technology as a member of the Validation Department’s support of BCG Operations

Qualifications Required:

•5 or more years cleaning validation experience in GMP Pharmaceutical manufacturing environment

•Experience preparing/authoring technical documentation / validation protocols

•Effective communication - both verbal and written

•Demonstrated collaboration and teamwork skills

•Demonstrated independent project management skills

•Passing medical surveillance test results for Tice®BCG

Preferred:

•B.S. (or equivalent 4-year degree) in Biology, Engineering or Science

•Previous experience with biologics and/or vaccines

•Previous experience with washers (parts/equipment, bead, and/or glass vial)

•Previous experience with manual and ultra-sonic cleaning methods

Scope:

The scope of activities is not limited to:

Equipment cleaning validation/qualification activities (IQ, OQ, PQ) associated with the following processes:

•Stainless Steel Bead Washer

•Pass-Through Parts Washer

•Double-Door Lyophilization Chamber – Manual Cleaning

•Ultra-Sonic Cleaner (small parts)

•The successful candidate must be a self-starter, with strong analytical problem solving skills, independent project management experience, with well-established technical writing skills

•The successful candidate should be able to examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to prepare, field-verify, approve, execute, and summarize cleaning validation protocols

Primary Activities:

•Author technical cleaning validation documents such as protocols, feasibility studies, and deviation investigations that align with corporate standards and industry requirements

•Adhere to Change Control procedures and ensure processes are maintained in a validated state through re-certification / re-validation activities

•Provide technical and/or investigational support in troubleshooting and resolving manufacturing process issues

•Partner (collaborate) with other internal departments (Operations, Quality, Plant Engineering, and Technology), and external centers of excellence (COEs) on cleaning validation related activities/events (e.g. laboratory testing)