30 days old

Qualification Engineer

Kelly Services
Elizabeth, NJ 07207
Kelly Science & Clinical is currently seeking a **Qualification Engineer** for a 6-month engagement at one of our Global Pharma customers in Elizabeth/Edison, NJ

This role is a full-time, fully benefitted position. As a Kelly employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation, and sick/personal time.


The Qualification Engineer II has responsibilities for equipment and utilities qualification, commissioning and improvement activities.

Individual is responsible to lead equipment qualification projects.

Responsibilities include performing equipment, utility and facility qualification activities in addition to support of engineering process improvement projects.

**Essential Duties / Functions**

Support Site Expansion and Renovation activities including Commissioning and Qualification for Facility, Utility and Equipment related systems.

Write Validation / Qualification protocols and reports that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment.

Analyze data to ascertain if it meets related protocol acceptance criteria; write deviation reports as required upon failures to meet protocol acceptance criteria.

Compile information from engineering turnover packages and engineering design documentation to support qualification.

Participate in factory acceptance testing and provide commissioning support.

Work with Engineering, Operations and R&D to facilitate the launch of new products in an efficient manner. Serve as a technical resource for Engineering and Operations for equipment/process capability and qualification requirements.

Prepare URS/FRS documents for required equipment for validation related projects.

Prepare and Execute Engineering Studies to establish equipment operating parameters.

Support activities to meet the requirements of the approved Site Validation Master Plan and Validation Project Plans.

Monitor all activities through completion, develop and communicate project timelines and status.

Work in self-directed manner and must be able to work on problems of a complex scope where analysis of data requires and in-depth evaluation of various factors.

Other duties as assigned by the Qualification/Engineering management.

**Qualification and Requirements**

MUST HAVE equipment qualification and computer system validation experience.

BS in Engineering (or other sciences).

At minimum, five years of Qualification/Engineering experience in the Pharmaceutical industry specialized in solid oral dose.

In depth understanding of pharmaceutical equipment function and operation.

Experience in general quality assurance methods and practices in equipment / process / product validation, quality improvement, quality management systems, corrective and preventive action, root cause analysis.

Basic understanding of common GMP utilities such as HVAC and compressed air systems.

Experience with automated control systems such as programmable logic controllers.

Specialized or Technical Knowledge, Licenses, Certifications required

cGMP Compliance and FDA PAI and Post Approval Inspection experience is required.

Diverse exposure to dosage forms including solid dosage forms. Exposure to both Rx and OTC products is desirable but Rx product experience is required.

Knowledge of pharmaceutical manufacturing operations to support the approval of protocols, reports, procedures and specifications.

Knowledge of for technical transfer of new and reformulated products including process scale-up and manufacture of pivotal batches.

Knowledge of regulatory requirements/guidelines

Excellent technical writing, analytical and interpersonal skills.

Proficiency in Microsoft office tools (excel, word, power point, Access, Project)

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you 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. 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-01-29 Expires: 2021-03-04

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Qualification Engineer

Kelly Services
Elizabeth, NJ 07207

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