Commissioning and Qualification Engineer - Pharma Biotech Research and Development

Location: Reading, PA
Date Posted: 07-06-2017
Position Title          Commissioning and Qualification Engineer - Pharma Biotech Research and Development - PA #3762
 
Relocation               Yes
 
Location                  Reading PA
 
A Commissioning and Qualification (C&Q) Engineer responsible for the authoring and execution of test protocols for startup, commissioning, and qualification activities.  The C&Q Engineer may also be called on to provide input for process and instrument and control design activities.  This individual must be capable of working in an interdisciplinary environment as a contributing team member and independently on a wide variety of projects.
 
Typical Duties:
*           Author startup, commissioning, and qualification test protocols for mechanical, electrical, and automated systems.
*           Field execution of test protocols for mechanical, electrical, and automated systems.
*           Temperature mapping of controlled temperature units (freezers, refrigerators, incubators, etc.) as well as sterilization processes.
*           Represent company at onsite client meetings.
*           Interact with clients, managers, vendors, contractors, and colleagues within the company.
 
Additional Responsibilities:
*           Interact with a variety of departments such as Validation, Engineering, Project Management and Quality Assurance, among others.
*           Provide on-site startup, troubleshooting, and engineering services support to the client.
*           Provide process and instrument and control design support.
*           Identify new work opportunities and submit proposals.
 
Education/Experience:
*           Engineering or science degree from ABET accredited university program.
*           Minimum of two to four years related experience within a manufacturing environment.
*           Must have experience with DCS, PLC, and other local or remote automation and control systems.
*           Experience in a FDA regulated environment is a plus.
*           Experience with LEED or building commissioning projects is a plus.
 
Skills and Special Requirements/Licensing:
*           Excellent attitude, attention to detail and interpersonal relationship skills.
*           Excellent documentation practices.
*           Excellent organizational skills.
*           Self-motivated and driven to succeed.
 
Work Environmental & Physical Demands:
*           Must be willing and able to work additional or off hours on projects as required to satisfy the client's deadlines.
*           Must be will and able to travel to client sites for test execution in laboratory, manufacturing, or office environments.
*           Capable of working independently and within a team framework.
*           Sensitive to client's needs and demands.
*           Ability to work within project budget and schedule requirements.
*           Capable of multi-tasking on different projects.
 
 
Bottom line requirements we need notes on with candidate submittal:
 
1.  Engineering or science degree from ABET accredited university program.
2.  2+ years of experience with test protocols for startup, commissioning, and qualification activities within a Pharma / Biotech manufacturing environment.
3.  Experience with DCS, PLC, and other local or remote automation and control systems.
 
4.  Experience in a FDA regulated environment is a plus.
5.  Experience with LEED or building commissioning projects is a plus.
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