Validation Engineer

PioneerDataSystems1

Valley Falls, KS, United States contract

Posted: November 21, 2017

Job Description

Job Description: 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.
• Will participate in team led by Pfizer group leaders.

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

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

Anuj Mehta

732-947-3452

Why Apply Through MisuJob?

AI-Powered Job Matching: MisuJob uses advanced artificial intelligence to analyze your skills, experience, and career goals. Our matching algorithm compares your profile against thousands of job requirements to find positions where you have the highest chance of success. This saves you hours of manual job searching and ensures you only see relevant opportunities.

One-Click Applications: Once you create your profile, applying to jobs is effortless. Your resume and cover letter are automatically tailored to highlight the most relevant experience for each position. You can apply to multiple jobs in minutes, not hours.

Career Intelligence: Beyond job matching, MisuJob provides valuable career insights. See how your skills compare to market demands, identify skill gaps to address, and understand salary benchmarks for your experience level. Make data-driven decisions about your career path.

Frequently Asked Questions

How do I apply for this position?

Click the "Register to Apply" button above to create a free MisuJob account. Once registered, you can apply with one click and track your application status in your dashboard.

Is MisuJob free for job seekers?

Yes, MisuJob is completely free for job seekers. Create your profile, get matched with jobs, and apply without any cost. We help you find your dream job without any hidden fees.

How does AI matching work?

Our AI analyzes your resume, skills, and experience to understand your professional profile. It then compares this against job requirements using natural language processing to calculate a match percentage. Higher matches mean better fit for the role.

Can I apply to jobs in other countries?

Absolutely. MisuJob features jobs from companies worldwide, including remote positions. Filter by location or look for remote opportunities to find jobs that match your preferences.

Ready to Apply?

Join thousands of job seekers using MisuJob's AI to find and apply to their dream jobs automatically.