|Reference # :||19-00259||Title :||Validation Qualification Engineer|
|Location :||Rocky Mount, NC|
|Position Type :||Contract|
|Experience Level :||5 Years||Start Date / End Date :||03/04/2019 / 09/03/2019|
| Location: Rocky Mount, NC |
Resource#: 1-2 Consultants- Mid Level Experience 5-8 years
Job Title: Validation/Qualification Engineer Formulation
Start Date: January 21
Our customer is a leading Global Pharmaceutical Company
Exciting opportunity to be part of a Pharmaceutical Facility expansion Project.
MUST have diverse facility, utility, and equipment Qualification and Validation experience.
RCM seeks 2 Jr. to mid-level consultants will be involved with the qualification of the automated systems for the tanks in the formulation area. Overall Commissioning should be completed by February. Experience with computer systems validation is very helpful since all the tank systems have complexities involving the customization of code of large scale systems. Formulation area has 3 different systems and in total 32 tanks.
The experience to validate, author IQs and execute protocols in support of validating the portable tanks is key or the Jr role. Experience with tank qualification along with CSV /GMP expertise in support of validating multiple and complex custom-coded systems and coding knowledge is a specialization that is key ito validate the tanks in the formulary area.
The purpose of these roles is to perform qualification and validation activities for a new facility expansion project. This project includes a large addition to the current structure and activities will included but not be limited to: new filling lines, tanks, utilities, aseptic fillers, autoclaves, parts, washers, sterilizers, transfer panels and multiple other equipment.
· Provide services and knowledge in the areas of qualification, commissioning and validation consultation and guidance to the validation organization on the implementation of compliant cost effective GMP activities.
· Validation team will provide services in support of the qualification and validation cycle as defined by the clients cGMP policies and procedures e.g. SOP's, Validation Plans, Protocol creation and execution (IQ,OQ,PQ), testing strategy, GMP requirements, Test Plans and Validation Summaries including writing and resolving deviations and change controls.
· Provides Quality and Validation knowledge, insights and in utilization of Facilities, Utilities and equipment in scope.of this project.
· The team will provide full life cycle Authority for specific qualification and validation documentation including, SOP's, protocols, change management, investigations and summaries.
· Provide Qualification, Commissioning and Validation expertise as requested to other internal customers.
The required skills include but are not limited to experience with 5-10 years validation and qualification in the pharmaceutical or Biotech industry. Strong documentation skills. Writing and executing protocols for facilities, mapping, and qualification of utilities. Experience with sterilizers, parts, washers and aseptic filling lines etc.