Manufacturing Support Process Engineer

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth.

IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ.

We have been honored by the following:

Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009
Top 500 Privately-Held Business in the US
Top 500 Diversity Owned Business in the US
Top 100 Subcontinent Asian American Business in the US
We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009.

The Manufacturing Operations Support Engineer will provide on floor technical support to manufacturing operations, work with investigation teams in solving complex manufacturing issues, identify opportunities to improve manufacturing processes and cGMP documentation and analyze manufacturing process control data.

Technical Support

• Provides daily on-the-floor technical support to manufacturing operations.
• Write and review batch records.
• Identify areas of process risk identify, assess, and implement risk mitigation strategies.
• Tracks, trends, and communicates process performance.

Validation

• Leads process validation and verification efforts.
• Possesses an understanding of the principles related to the validated states of the process and process equipment.

Training/Compliance

• Promote “Right First Time” philosophy for all manufacturing activities.
• Provide technical training to manufacturing personnel.
• Participate in change controls and product deviation investigations.

Deviation Management

• Ensures manufacturing staff identify and document events that deviate from normal operation.
• Provide technical support to deviation investigations.
• Completes investigations, reports, and proposes CAPA for minor deviations.

Continuous Improvement

• Supports plant floor continuous improvement initiatives (Process and Value Stream Mapping).
• Supports the creation manufacturing SOP’s that ensures manufacturing operations stay aligned with the validated process.

Basic Qualifications:

• BS in Chemical or Biochemical Engineering (or similar) with 0-2 years manufacturing floor experience.
• Demonstrated understanding of biologics manufacturing, scale-up and validation principles.
• Excellent problem solver and ability to generate innovative solutions to broad range of issues.
• Good understanding of experimental design and statistical process evaluation.
• Ability to explain complex technical issues to other functions in clear and understandable terms.

Preferred Qualifications:

• Familiarity with one or more upstream or downstream process unit operation design typically used in biotech manufacturing (cell expansion, fermentation & cell culture, harvest / clarification, purification).
• Previous experience with process or equipment validation
• Ability to evaluate new technologies/techniques.

All your information will be kept confidential according to EEO guidelines.