Validations Engineer II

PBI-Gordon Companies•Pensacola, FL

32d

About The Position

The Validation Engineer II is responsible for process and product validation from equipment design to FDA approval and continued process verification. This position manages projects with Operations for the commissioning and qualification of equipment to maximize efficiency, safety, continuous improvement and apply lean manufacturing principles and techniques.

Requirements

Education: BS with 2-5 years of relevant experience or MS or PhD in Chemical or Mechanical Engineering or a related discipline.
Experience: Must have 2+ years Pharmaceutical Process Development and Validations experience, 5+ years is preferred.
Specialized knowledge or training: Experience with Process Validations, Cleaning Validations, Scale-up, and equipment qualifications.
Other Skills: Strong Technical writing and documentation skills are necessary (cGMP, protocols, reports, OOS investigations, and laboratory notebook documentation).

Nice To Haves

Experience with performing IQ, OQ and PQ functions for equipment used on different products (tablets, solutions, or topicals), Statistical process performance and Project Management are a plus.

Responsibilities

Oversee manufacturing equipment and facility commissioning projects including design, selection, and qualification.
Develop protocols and write reports; to appropriately design the protocols, must be able to understand the purpose and objective of the study.
Able to write and execute IQ, OQ and PQ protocols against project timelines.
Has effective organization and time management skills.
Multi-tasks well, delegates appropriately and considers others when planning.
Develops effective plans, anticipates problems and looks for contingencies.
Supports project technical development (Manufacturing Controls), from formulations to approval and launch as it applies to project design.
Works with Formulators during laboratory batches to understand the process.
Is able to navigate complex projects and view problems as opportunities.
Shows confidence in ambiguous and stressful situations.
Solicits and welcomes feedback from others.
Able to design and perform the execution of sampling and sample preparation in support of cleaning, process, and packaging validation protocols.
Must be able to analyze and review raw data and interpret results.
Write final reports in accordance with industry and company standards.
Able to build strong relationships and relate well with the different departments to reach common corporate goals.
Managing and monitors assigned product validation projects including cleaning and manufacturing processes.
Utilize a risk-based approach to establish and maintain the validation program specific to product.
Responsible for project planning and justification; works with various departments to develop project budgets and timelines to manage the project effectively.
Identifies and translates priorities into clear, actionable goals and tactics.
Accountable for training manufacturing and production personnel on new equipment, cleaning procedures, and manufacturing processes.
Build strong relationships and relate well with others to drive results to meet personal, company and corporate goals.
Shows personal commitment and takes actions to continuously improve.
Accepts opportunities that broaden capabilities.
Applies what has been learned to improve future experiences for self, others, and company.
Other duties as assigned.