Qualification Validation Engineer

TOWER LABORATORIES LTD.•Montague Township, MI

3d•Onsite

About The Position

This position is responsible for initiating, conducting and implementing engineering evaluations, new equipment or processes installations (in coordination with Staff Engineer and Facilities Manager), design and general improvements associated with the manufacturing processes at Tower Laboratories. These activities support operational requirements to maximize operating effectiveness as well as fulfilling the need to document manufacturing systems and satisfy regulatory requirements.

Requirements

Minimum 2 years experience in chemical engineering
Computer literate with spreadsheet, databases and CAD
Familiarity with SPC & IE analysis techniques
Strong problem analysis and problem resolution at both a strategic and a functional level
Strong verbal and written communication skills
Ability to organize and manage multiple projects
Ability to communicate effectively with team members and other plant personnel

Nice To Haves

Technical engineering degree required; Bachelor’s degree in an engineering discipline preferred

Responsibilities

Write and perform qualifications and validations for products and processes
Write and execute IQ, OQ and PQ on manufacturing equipment
Prepare annual reports to assess product trends, submit recommendations to management by summarizing and analyzing the processes, develops action plan to correct the issues highlighted in the evaluations
Writes specifications and procedures
Interfaces with R&D in new product development by working with department on scale-ups and new product development
Conducts internal as well as external audits as needed
Reviews existing manufacturing processes and leads a team of representatives from a number of departments in improving the processes
Interfaces with customers on the transfer and implementation of manufacturing process
Conducts related training when needed
Performs evaluations, conducts research and initiates compatibility studies on alternate materials
Assists in the writing and reviewing of new Batch Records
Interfaces on technical issues between the Manufacturing and Technical Departments
Performs all work in accordance with established Safety, cGMP and company procedures
Other related responsibilities as assigned other duties as requested