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Sr. Validation Engineer

Merck
Indianapolis, USA
Full-time
Senior · 9+ years experience
Onsite
Discovered 2 weeks ago

Full Job Posting

Minimum Qualifications:

  • B.S. in science or engineering related field and 7 years validation experience or equivalent combination of two-year degree and a minimum of 9 years validation experience in an aseptic pharmaceutical setting focused on equipment cleaning (automated and manual).
  • Experience with aseptic bulk process formulation, aseptic filling, process and packaging equipment, computer systems, process control systems, equipment cleaning and sterility assurance required.

Preferred Qualifications:

  • Experience with various types of validation test equipment, such as: Kaye Validator, Val Probe, PLC, Temperature/Pressure standards.
  • Prior experience (required) in the qualification of various types of sterile filling facility equipment, such as:
  • o Sterilization Technology (Steam, Dry Heat, VHP, etc.)
  • o Temperature Mapping (Various chambers)
  • o Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc.)
  • o Pharmaceutical Grade Utilities
  • o Process Validation
  • o Cleaning Validation
  • Hands-on skills are necessary.
  • Expertise with Windows based Personal Computers.
  • Above average PC skills with spreadsheets, word processing and databases.
  • Employee must be self-motivated, highly organized, and conscientious.
  • Must be able to work and make decisions independently as well as with a team.
  • Must be able to work in technically and mentally demanding situations.
  • Strong verbal and written communications skills are required.
  • This role requires regular access to process areas by climbing stairs and ladders and performing work in those areas.
  • Employee must be available to work various shifts and weekends to support the Validation Schedule.
  • Proficiency with statistical analysis tools and the ability to interpret and present complex data sets.
  • Pay Range for this position: $111,200 - $166,800
  • The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
  • What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
  • Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

Responsibilities

  • Validation is the backbone of pharmaceutical manufacturing quality — and in this role, you will own it. As a Sr. Validation Engineer, you will lead and execute validation activities across a complex aseptic manufacturing site, with a primary focus on the cleaning validation program. You will research, author, coordinate, and execute validation protocols covering process, equipment, facility, utilities, computerized systems, and cleaning. Working with considerable autonomy, you will review and summarize data for management approval, perform revalidations, assess the impact of change control requests, and create and update standard operating procedures. You will also serve as validation lead on cross-functional projects, develop validation master plans, and support media fills. Your technical depth and independent judgment will directly protect product quality and regulatory compliance.

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