Senior Validation Engineer

Company: Sovereign Technologies
Location: Mount Prospect
Posted on: April 5, 2025

Job Description:

Job Description:

Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.

Pharmaceutical experience, ideally with cleaning validation expertise.

Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies. Oversees and reviews validation area processes.

Design and develop cleaning procedures for new products and manufacturing equipment.
Provide technical support to cleaning activities associated with the manufacturing process.
Use of cleaning agents and the establishment of sound cleaning practices within new or refurbished manufacturing rooms and sampling suites areas.
Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.
Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.
Leads the enhancement of cleaning practices, "clean in place" (CIP) equipment and introduction.
Reviews and approves Manufacturing Cleaning Working Instructions and Forms.
Supports the periodic review of cleaning validation studies.
Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
Trains manufacturing and QC/QA personnel on cleaning validation documentation.



Qualifications

Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
Strong project management skills.
Experience mixing solutions (formulations)
Proficient time management skills, planning and organization capabilities.
Proven leadership & teamwork skills, self-starter, results oriented and build and maintain strong relationships with multiple groups.
Proficient in Risk Assessment/Management
Proven assessment, analytical and problem-solving skills.
Proficient presentation skills and Technical Writing/Oral communication skills (English)
Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.

Keywords: Sovereign Technologies, South Bend , Senior Validation Engineer, Engineering , Mount Prospect, Indiana