1+ months

Validation Engineer

Kelly Services
Pittsburgh, PA 15222
**Qualification Engineer**

The Qualification Engineer is responsible for the successful planning, design, execution and control of the qualification and implementation of Equipment and Facility systems. This person will be responsible for executing validation projects in the biopharmaceutical industry.

**Job Duties:**

+ Provide direct technical expertise regarding the validation requirements of equipment, facilities, and utilities including design reviews, document generation (URS, IQ, OQ, PQ protocols, SOPs, summary reports), and validation protocol execution.

+ Install and qualify equipment, including communication of GMP system turnover to system owners

+ Qualify facility spaces, including classified areas such as Cleanrooms

+ Qualify utilities including but not limited to Air Handling Units, Water Systems, CO2 Systems, and Liquid Nitrogen Systems

+ Author impact assessments for assets to determine downstream qualification activities

+ Author, identify and organizing user requirements specifications

+ Investigate protocol exceptions during qualification, including leading any retesting or corrective actions

+ Understand and comply with industry standards including International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and United States Pharmacopeia (USP)

**Skills Needed:**

+ Maintain regular and punctual attendance

+ Must maintain company quality and safety standards

+ Ability to work in collaborative and independent work situations and environments with minimal supervision

+ Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability

+ Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals

+ Trainability

+ Must have effective verbal, written and interpersonal skills

+ Able to prioritize and operate proactively

+ Must exhibit well developed skills in prioritizing, planning, organization, decision making, and time management

+ Maintain frequent communication with System Owners, Validation Management, Project Managers, and other support functions

**Education** :

+ Bachelors Degree


+ 4 years of experience with Qualification activities

+ Knowledge of GEPs

+ Knowledge of risk-based engineering methods and industry guidance documentation (i.e ISPE)

+ Knowledge of Quality Risk Management


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-08-26 Expires: 2022-10-27

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Validation Engineer

Kelly Services
Pittsburgh, PA 15222

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