KellyOCG, a managed solution provider, is currently seeking an Equipment Qualification Engineer for one of our Global clients. This role is a full-time, fully benefitted contract position that will go through March 2021.
As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. You'll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.
Position Summary / Objective:
The Qualification Engineer has responsibilities for equipment and utilities qualification, commissioning and improvement activities at sites located in Edison, NJ and Elizabeth, NJ.
MUST HAVE equipment qualification and computer system validation experience.
Equipment experience: tablet press, encapsulator, fluid bed, filler, capper, labeler, checkweigher, etc.
- Lead equipment qualification projects.
- Perform 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 an in-depth evaluation of various factors.
- Other duties as assigned by the Qualification/Engineering management.
Qualifications and Requirements
- BS in Engineering or other sciences.
- At least 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
- 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 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, PowerPoint, Access,
To learn more about KellyOCG and our Managed Solutions expertise, visit us at kellyocg.com/Solutions/Business-and-Professional Services.
Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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