Commissioning Qualification Engineer - Long Term Opportunity

Apply by eMail:15349052.185@jobfrenzy1.com

Description:
GENERAL PURPOSE OF JOB
Develop and/or execute equipment and utility commissioning and qualification test plans for API facility start-up.

ESSENTIAL DUTIES
Develop URS in accordance with owners URS procedures
Assist in development and execution of product and process based and/or component based risk assessment.
Assist the risk assessment with identification of product and process hazards and risk control mechanisms.
Assist the risk assessment with identification of critical/non-critical systems and components.
Develop static and operational test plans to support commissioning/qualification requirements for utilities, process equipment and process automation.
Execute test plans to support static and operational commissioning/qualification requirements for utilities, process equipment and process automation.
Operate complex utility and process equipment, particularly using automated controls.
Set-up and maintain equipment files.

SPECIFIC KNOWLEGDE
Commissioning and Qualification of pharmaceutical manufacturing equipment, systems, process automation, and facilities
API Processes and Utilities
Static test protocol development
Functional test protocol development
Pharmaceutical Quality Systems

ADDITIONAL POSITION REQUIREMENTS
Carries out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA and DEA. Complies with all company and site policies and procedures.
Assume responsibility for the environmental effects of work performed and for the identification and recording of environmental problems as they arise.
Understands and responsibly performs duties with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), and maintaining proper housekeeping at all times.
Successfully completes regulatory and job training requirements.


QUALIFICATIONS, EDUCATION and/or EXPERIENCE
Bachelors degree or equivalent in an Engineering field with 5+ years experience; or 7 to 10 years related experience and/or training; or equivalent combination of education and experience. Five + years experience in commissioning/qualification large ( $5MM) capital projects required. Experience in API pharmaceuticals and GMP operations required. Experience in DCS controlled operations preferred.

TEAM SKILLS
Effectively present information to project management.
Analyze and interpret complex technical problems and formulate appropriate solutions.
Making suggestions for improvement.
Interact with personnel from all levels of the organization in a team environment.
Successfully complete regulatory and job training requirements.
Perform a variety of duties, maintain attention to detail and speed without a loss of productivity.

MATHEMATICAL SKILLS
Apply mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Requirements:


Education: Not Specified

Experience: Not Specified

Travel: Not Specified

Apply by eMail:15349052.185@jobfrenzy1.com

Job Created: Fri Oct 30 2009 04:27:20 AM
Last Modified: Fri Oct 30 2009 04:27:20 AM