Engineer / Validation Specialist
Validation Technologies, Inc. (Allentown, Pennsylvania)

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Committed to Biotech Manufacture? So are we.

 
VTI is committed to providing first class engineering, validation and technical services to the Biotech and Biologicals industry.  We strive to create a work environment that is personally rewarding, and characterized by professionalism, technical excellence and opportunities for growth.  For more information about the company, please visit our website at www.validation.org.

 
Position Summary:

Validation Technologies, Inc. is seeking an Engineer or Validation Specialist to work on projects in the New York, New Jersey and Pennsylvania areas.

The position involves a wide variety of activities relating to the manufacture of biotech products, including: performing commissioning, process engineering, cycle development, acceptance testing and validation in cGMP compliant manufacturing facilities and QC test laboratories.

As a consultant, you will gain a wealth of experience through exposure to best engineering practices, novel process technologies and diverse corporate cultures.

Responsibilities:

Responsibilities typically performed by our Engineers and Validation Specialists include:

The development of documents, execution of tests and preparation of final reports. Analyzing data, determining results and the presentation of conclusions and recommendations to clients, in accordance with project timelines, policies and proceduresReviewing GXP deliverables including specifications, critical drawings, manuals, trace matrices, turn-over packages, procedural documents, master plans, maintenance plans and validation documentationTroubleshooting system failuresOptimizing processes and equipment Performing control software evaluation and auditsProviding technical leadership and support within the client organization and to peers in VTITraining operations staff on protocols, procedures and technical details related to systems or processesOrganize, schedule and track validation projects in order to meet client requirements and agreed timelinesSome travel may be required within the U.S.

VTI offers an excellent benefits package to its employees.

Requirements:

Dynamic interpersonal and teamwork skillsBachelors or Masters degree in Engineering, Chemistry or Biological Science with 2-5 years (Engineer/Specialist) or 5-8 yrs (Sr. Engineer/ Sr. Specialist) experience in biotech, medical device or pharmaceutical industries. Manufacturing or analytical test experience may be considered applicable to this requirementHands-on engineering or validation experience is required with at least three of the following systems or processes: critical utilities (WFI, USP purified water, clean steam, clean compressed gasses, HVAC) CIP systems, SIP systems, PLC or DCS control systems, buffer prep, cell culture and purification processes, autoclaves, environmentally controlled chambers, classified cleanrooms, laboratory analytical equipmentWorking knowledge of a cGMP regulatory environment, cGMP guidance’s and best practices is required. Experience with EU regulatory requirements is a plusMust have strong written and verbal communication skills Demonstrated skills in experimental design and problem solvingMust also have strong organizational skills and be able to execute and manage projects to completionExperience in discrepancy and non-conformance reporting, corrective action/preventive action systems and root cause analysisExpert skills in Microsoft Office applications. Experience with the following applications is desirable; Visio, Documentum, LIMS, Trackwise

Physical Demands

Lifting Limits: Up to 50 lbsWork Environment: standing for extended periods; access to platforms, ladders, spaces with limited ingress and egress; gowning for cleanroom entry is usually necessary