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Old 12-12-2012, 06:17 PM   #842
Scooby Specialist
Member#: 154369
Join Date: Jul 2007
Chapter/Region: Tri-State
2013 SWP WRX


Figured I'd post up the job ops my company has open. Currently 2 Computer Engineer positions. These are not entry-level positions, experience a must. (Pharmaceutical Industry). Bridgewater/Branchburg NJ area

First Position (Engineer II):
This position requires an individual with a thorough knowledge of of biopharmaceutical validation, compliance regulations, and excellent problem solving skills.

Responsibilities will include the following:

  • coordinate validation project activities,
  • write and review validation policies/SOPs,
  • develop and execute cleaning validation,
  • cleaning verification,
  • equipment qualification protocols as required.
Must have the ability to integrate differing solutions into a cohesive and well-structured quality plan.
Using effective project management skills, must deliver projects on time and within budget.
Develop and/or review IQ/OQ/PQ protocols, studies, SOPs, validation master plans, technical reports and final reports as required.
Provide technical evaluations of complex validation issues supporting investigations and change controls; provide technical solutions to validation issues and develop corrective action plans, as required.
Use effective project management and leadership skills to supervise validation project teams including validation contractors and vendors.
Have appropriate knowledge of schedule, budget, and scope.
Prepare agendas, issue meeting minutes and communicate status to management and customer departments

Bachelor’s degree in Engineering, Science, or related discipline.

Minimum 2 years (P1) to 5 years (P3) experience performing projects of moderate to complex scope that involved qualification of facilities, utilities, process, cleaning, or support equipment.

Must demonstrate sufficient knowledge of validation requirements and cGMPs to perform duties.

Must understand the lifecycle approach and risk based approach to validation including the role of user and functional requirements as supporting documentation for validation.

Must have project management skills sufficient to complete complex activities while directing contract service providers or junior team members.

Must have the ability and knowledge to manage highly complex projects where collaboration with customer groups is key to success.

Excellent verbal (both oral and written) communication skills

Second Position (Engineer III):
Engineer III leads the implementation of projects to enhance and improve quality processes at COMPANY by utilizing current automated quality systems platforms. Works with cross-functional groups in the design and build out of systems. Authors and executes validation plans, protocols and reports for new or upgraded systems. Provides day to day maintenance and support of existing systems.
  • Work with cross-functional groups in the technical design and system configuration of new or upgraded Quality Systems that will be used to support commercial and clinical operations.
  • Work with cross-functional groups to examine process/procedural issues and make recommendations to Quality Systems Management on potential solutions for implementation.
  • Participate as a Quality Systems technical liaison to cross-functional committees to help ensure integration within various Quality Systems is feasible.
  • Develop and execute validation plans, protocols and associated documentation related to project work.
  • Provide end user support, report generation, and other duties as assigned by area manager

  • Bachelor of Science degree in a computer related field. Work experience will be considered in lieu of BS. Two years work experience for each year in study will be considered. Minimum of 6 years pharma/biotech experience within an IT or Automated Quality Systems role.
  • Intermediate to advanced knowledge of general computing principles.
  • Intermediate to advanced knowledge of GxP regulations (specifically, 21CFR11).
  • Intermediate knowledge of system architecture (Servers, pc, networking).
  • Ability to work independently as well as within a cross-functional project team.
  • Self starter and self motivated is a must
  • Knowledge of at least one programming language and associated programming methodologies (SDLC) is preferred
If any one meets the requirements and is interested send me a pm and we can talk.
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