Sr. Validation Engineer

Merck•Indianapolis, IN

2d•Onsite

About The Position

This role is for a Sr. Validation Engineer at MilliporeSigma, focusing on leading and executing validation activities within a complex aseptic manufacturing site. The primary focus will be on the cleaning validation program. The engineer will be responsible for researching, authoring, coordinating, and executing validation protocols for processes, equipment, facilities, utilities, computerized systems, and cleaning. This role requires a significant degree of autonomy, including reviewing and summarizing data for management, performing revalidations, assessing change control impacts, and updating standard operating procedures. The engineer will also act as a validation lead on cross-functional projects, develop validation master plans, and support media fills. The technical expertise and independent judgment of this role are crucial for protecting product quality and ensuring 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.
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.
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 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.

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.