Posted to MedZilla on 1/8/2018

Sunrise Systems Inc

US-KS, Pharmaceutical Validation Engineer 17-14549-MZ


Job Title: Pharmaceutical Validation Engineer

Job ID : 17-14549

Duration: 4-5 Months’ W2- Contract, W2- (Contract to hire)

Location: McPherson, KS 67460

Position Summary

Validation engineer with experience in equipment, HVAC, utility and process qualification within a pharmaceutical industry. Previous plant experience is recommended. Background in aseptic processing, microbiology, environmental monitoring, chemistry, and production is recommended. The additional resources are requested for a total of fourteen (14) weeks starting in December 2017 and ending March 2018 to support Winter Shutdown changes. Hours can involve weekend or night shifts. Validation activities including writing system impact assessments, oversight of engineering during shutdown activities, execution of installation qualification, operational qualification, performance qualification, and summarizing qualification results/drafting qualification report summaries. The support staff must act in accordance with plant safety requirements, training and procedures.

Position Responsibilities

Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.

Coordinates and communicates all testing with affected functional groups and evaluates test results.

Executes equipment, facility, utility and computer system, Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.

Oversee and assist Engineers and/or Technicians with their assigned projects.

Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.

Thorough understanding of risk based validation, industry standards and best practices for validation.

Organizational Relationships

Will interact with Shutdown stakeholders: Engineering, Operations, Quality, Safety, Planning, Contractors, etc.

Weekly/daily meeting attendance as required.

Technical Skills Requirements

Knowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing

Physical Position Requirements

Logistics: Requires contractor to be on-site weekly with travel home every other weekend

Must be able and willing to work beyond office hours which may include weekends.

Requires routine sitting, standing, walking, listening and talking

Acute mental and visual attention at all times

Handle multiple projects while managing frequent interruptions

Requires moderate lifting or moving up to 25 pounds (lbs)

Education And Experience

Education: BS/BA degree in science, engineering, manufacturing technology or closely related field or combination of education and work experience

Experience: Recommended minimum of 4 years pharmaceutical validation experience


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