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Who Core Reliance is

Our Employees Have a Unique Set of Credentials

CoreEmployeesCore Reliance engineers come from top engineering schools. That’s a given. So you know that their degrees in chemical, mechanical, or electrical engineering are top-notch and hard-earned.

But academics are only a starting point. We make sure that our engineers have not only book-learning, but also practical execution capability. For example, we’re pretty sure we’re the only engineering firm where one of the employment qualifications is that you can change a set of brake pads on your car.

We also have people who are multi-dimensional, because our business is not just working with equipment: it’s relating to the people we work with, understanding how to give and take information, and working well within a team structure. So our engineers excel at something besides work — they mentor others, or play a sport, or are active in an organization. Those people skills are really important when you’re in the middle of a project: when tension is high and patience is low, we know how to defuse the situation.

Something else that makes us different: we concentrate on developing our team. When someone moves from acting as a Project Engineer to Senior Project Engineer at Core Reliance, it’s in part because they’ve gained expertise in at least six fields of aseptic processing specialty.  Our engineers are encouraged to challenge themselves, and with personal dedication, mentoring, and a variety of project opportunities, a strong Core Reliance team is realized.

Our Roles

The principal engineer, generally a subject matter expert in a variety of equipment and process specialties, provides the vision for the project, and manages high-level design decisions at the start of the project. The engineers performing the project and fieldwork receive guidance and support from the principal engineer.
Working under the guidance of the principal engineer, these team members are responsible for the day-to-day operations of a job: project management, information exchange, design input, and technical decisions. You’ll see them often, since they are your main contact points, and they are responsible for the directing the execution of the project.
Here’s the hands-on player: mechanically inclined, knows the equipment and the design and build basis, executes smartly and properly. Project engineers are eager, diligent, trustworthy and competent.  Fieldwork is performed under the supervision of the senior project engineer or project manager.
Not a Core Reliance employee, but a valued principal level resource, these partners are recognized industry leaders and subject matter experts in their fields of expertise.

Our Team

About Jeff

Jeff has over 20 years of experience in the field of aseptic processing and pharmaceutical technical project services. He provides engineering direction, support, and supervision in the design, procurement, equipment acceptance, ramp-up and qualification activities of pharmaceutical aseptic processing and secondary packaging lines.

Jeff’s technical proficiency and technical writing skills are backed by equally strong communication and leadership abilities, which have proven time and time again to be the factors that make a project into a success. He has the ability to lead a team and generate excitement while prioritizing details and getting the results you need.

Specific Expertise

  • Implementation and Start Up of Blend and Fill Manufacturing Areas
  • Performance Qualification of Autoclave Sterilizers
  • Performance Qualification for Steam In Place Cycle of Blend Tanks
  • Implementation of an Enclosed Blending Process for a Bulk Drug Substance
  • Transfer Validation of Volume Filled Sprayers in Nomadic Shipping Containers
  • FAT/SAT Execution, and Equipment IOQ/PQ Management
  • Equipment/System Certification Reports
  • Validation Packaging Line Improvements
  • Performance Qualification for Steam in Place Procedures of a Media Filter and Transfer Line used to add Media to the Bioreactor
  • Completion of Various Submissions for Sterile Regulatory Affairs
  • Composed and Submitted Original Abbreviated New Drug Applications for Sterile Regulatory Affairs

Education & Training

  • B.S., Chemical Engineering, Lehigh University
  • Completion of coursework, Risø High Dose Reference Laboratory
  • Validation and Process Control for Electron Beam Sterilization, August 25-29, 2008 (used for sanitization of Hypack Syringe Tubs)
  • Various testing techniques necessary for aseptic processing equipment qualifications

Memberships

  • International Society for Pharmaceutical Engineering
  • American Society of Mechanical Engineers
  • Parenteral Drug Association

About Ato

Ato has over 10 years of experience in the pharmaceutical industry. He provides engineering and validation assistance in the procurement, qualification, start-up and commercial ramp-up of pharmaceutical aseptic processing and packaging systems.

Ato has developed his technical writing skills through the generation of process and equipment validation protocols and summary reports. He perfected his investigational skills through drafting and managing validation and engineering deviations and non-conformances. He is trustworthy with high priority assignments and tasks including engineering studies, and investigational plans that have been submitted to various regulatory agencies. He provides leadership and establishes great cross-functional communication between various stakeholders to efficiently complete the task and project at hand.

Specific Expertise

  • Vial Line Design through commercial start-up
  • Syringe Line Design through commercial start-up
  • Secondary Packaging Line Design through commercial start-up
  • Isolation Technology: implementation and qualification
  • Filling Technologies, appropriate selection and project implementation
  • New Product Transfers to existing Filling Lines
  • Conversion of traditional product path to single use product path
  • Existing Equipment/Production Line Efficiency Improvement and Modification
  • Special Projects – Deviation Investigation, troubleshooting issues, general technical challenges
  • Existing Equipment/Production Line Efficiency Improvement and Modification
  • Special Projects – Deviation Investigation, troubleshooting issues, general technical challenges

Education & Training

  • B.S., Mechanical Engineering, Pennsylvania State University, University Park, PA
  • Graduate level coursework in GMP and Process Validation at Temple University