Dome-Tech Commissioning Services
Validation Engineer

Here is your opportunity to join a growing and respected firm in one of the fastest growing markets in the U.S. - validation and commissioning services.

Basic Qualifications:
qualified candidates will have a Bachelor's degree in engineering or other scientific field, or Associates degree in a technical discipline with 5-10 years experience in the pharmaceutical industry.

• Minimum 5-10 years of direct validation experience in the pharmaceutical industry
• Knowledgeable in cGMP's
• Strong planning, organizational and project management skills
• Strong technical understanding of the industry and validation practices related to the pharmaceutical industry
• Excellent verbal and written communication skills
• Demonstrated ability to interact well with peers, subordinates and senior personnel in multidisciplinary teams involving scientific, engineering and operational disciplines
•  Strong analysis and problem solving skills

Preferred Qualifications:

• Bachelor's Degree in Mechanical or Electrical Engineering
• Hands-on experience in validating HVAC and BMS equipment
• Experience validating critical HVAC utilities/ facilities (Purified Water, Compressed Air)
• Demonstrated ability to develop full life cycle validation documentation (Validation Plan, User Requirements, System Design Specification, Traceability Matrix, etc.)
• Knowledge in commissioning services

Scope:

• Provide technical expertise required for the development of validation protocols and for troubleshooting problems associated with protocol execution
• Develop rational equipment and/or system validation test plans
• Interact with representatives of Engineering, Maintenance, Calibration, Microbiology, Quality Assurance, IT and other staff both locally and trans-nationally

Job Responsibilities:

• Write validation protocols, reports and change control documents
• Coordinate, participate and lead resources required to complete validation studies and tests in order to meet agreed time lines
• Lead the effort to gain approval of validation protocols and final reports
• Make recommendations for improving validation projects
• Maintain validation documentation
• Develop and edit operating, maintenance, cleaning and/or calibration procedures
• Perform validation record reviews
• Provide validation leadership in the design installation installation of new systems modification modification to existing systems to ensure designs comply with current validation standards and are able to be adequately validated and maintained with validated protocol
• Stay current on developments in validation within the industry and regulatory agencies (FDA, ISPE)

Additional Information:
Dome-Tech offers a salary salary and attractive benefits that include medical/ dental insurance, mileage reimbursement, 401K with company match, flexible spending account, employee referral program, paid holidays and vacation.



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