Pharmaceutical Process Validation Specialist

Philadelphia, PA

Industry: Pharmaceutical Job Number: 133177
 
 

Pharmaceutical Process Validation Specialist

Environment:

Our client is a Drug Manufacturer who is currently in the process of starting  up a new drug substance manufacturing facility.

Job Duties/Responsibilities:

Candidate will be a member of the Manufacturing Technology – Viral Technology team providing technical and validation support for the start-up of a new influenza drug substance manufacturing facility. The candidate will be responsible for planning and execution of process definition, development, and validation preparation activities, in order to support a process demonstration scheduled to begin 1Q 2019. 

On a day to day basis this candidate will be supporting the development of validation strategy, including preparation of key documentation such as risk assessments, protocols and validation project plans. They will also  Gather and analyze information and data from regulations, industry practices, vendors, guidelines, procedures, historical reports, and existing manufacturing facilities on site, in order to design and support transfer and implementation of process in new facility. 

Design and execute engineering runs / process studies / equipment performance qualification / integrated functional testing, collate results and perform data analysis, interpret data, & draw conclusions.  Document and interpret study results providing recommendations back to project team and management.

Project work must be conducted independently with direction and oversight from the area technical lead, and requires successful application of scientific and engineering problem solving skills.  The candidate will also be required to obtain a basic working knowledge of company-specific systems, standards, and procedures.  Periodic checks and reports are required to review soundness of technical judgment and the status / schedule of the effort.

Required:

2-5 years of Pharmaceutical experience

Experience with PQ or Process Validation (PV/PPQ)

Degree in Chemical or Biological Engineering

Interpersonal skills

 

Desired:

Facility start up / Engineering runs

Experience with MS Visio, MS Project, Visual Basic, and Delta-V

Understanding of Aseptic Techniques and Basic Lab skills

 

Job Type: Contract 

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