Sr. Validation Engineer

The businesses of Merck KGaA, Darmstadt, Germany•Indianapolis, IN

3d•$111,200 - $166,800•Onsite

About The Position

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.

Requirements

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.
Expertise with Windows based Personal Computers.
Above average PC skills with spreadsheets, word processing and databases.
Strong verbal and written communications skills are required.
Proficiency with statistical analysis tools and the ability to interpret and present complex data sets.

Nice To Haves

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: Sterilization Technology (Steam, Dry Heat, VHP, etc.), Temperature Mapping (Various chambers), Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc.), Pharmaceutical Grade Utilities, Process Validation, Cleaning Validation.
Hands-on skills are necessary.
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.
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.

Responsibilities

Lead and execute validation activities across a complex aseptic manufacturing site, with a primary focus on the cleaning validation program.
Research, author, coordinate, and execute validation protocols covering process, equipment, facility, utilities, computerized systems, and cleaning.
Review and summarize data for management approval.
Perform revalidations.
Assess the impact of change control requests.
Create and update standard operating procedures.
Serve as validation lead on cross-functional projects.
Develop validation master plans.
Support media fills.