Endo · 1 day ago
Lead Validation Eng
St Louis, MO
Full-time
Onsite
Lead/Staff
10+ years expPar Health is committed to improving lives through quality healthcare, and they are seeking a Lead Validation Engineer. The role involves creating, reviewing, and executing validation activities for equipment and manufacturing processes, ensuring product quality and compliance with regulatory requirements.
Pharmaceuticals
Responsibilities
Development and execution of documents including but not limited to: FAT, SAT, IQ, OQ, PQ, and PV
Review and approval of validation documents including but not limited to: GxP Assessment, Risk Assessment, Part 11/Annex 11 Assessment, Data Integrity Assessments, IQ, OQ, PQ, Summary Reports, URS, FRS, DS and Traceability Matrix
Familiar with Development, QA and Production environment terminology and testing strategies
Complete equipment periodic review
Responsible for change management validation functional review
Temperature mapping of controlled environments
Development and review of laboratory equipment qualification protocols
Development and review of cleaning validation protocols. Basic understanding of LD50/HBEL derived maximum carryover limits
Collection of cleaning samples – swab / rinse, etc. as required
Performs validation document review and approval
Responsible for validation procedures, template creation and software validation process improvements
Reviews/approves validation deviation investigation
Develops validation plans for multiple site implementation
Responsible for document management including scanning and archival of validation documents
Familiar with data integrity guidance from MHRA and FDA
Management of data integrity gap assessments and remediation
Performs equipment/system/process level risk assessments per ICH Q9 guidelines
Provides audit support – customer/regulatory /corporate, etc. as needed
Perform various risk assessments with a cross functional group
Participate in site Environmental Health and Safety, Performance Excellence, Lean, Quality Improvement Plans, and related initiatives designed to meet key business objectives
Qualification
Required
Bachelor's degree in a science/engineering related field is preferable with related technical background
Minimum of 10 years' experience in review/approving validation in a pharmaceutical manufacturing environment
Proven personnel and project management history
Complete knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements
Knowledge of ICH Q7 , Q9, and Q11 preferred
Development and execution of documents including but not limited to: FAT, SAT, IQ, OQ, PQ, and PV
Review and approval of validation documents including but not limited to: GxP Assessment, Risk Assessment, Part 11/Annex 11 Assessment, Data Integrity Assessments, IQ, OQ, PQ, Summary Reports, URS, FRS, DS and Traceability Matrix
Familiar with Development, QA and Production environment terminology and testing strategies
Complete equipment periodic review
Responsible for change management validation functional review
Temperature mapping of controlled environments
Development and review of laboratory equipment qualification protocols
Development and review of cleaning validation protocols. Basic understanding of LD50/HBEL derived maximum carryover limits
Collection of cleaning samples – swab / rinse, etc. as required
Performs validation document review and approval
Responsible for validation procedures, template creation and software validation process improvements
Reviews/approves validation deviation investigation
Develops validation plans for multiple site implementation
Responsible for document management including scanning and archival of validation documents
Familiar with data integrity guidance from MHRA and FDA
Management of data integrity gap assessments and remediation
Performs equipment/system/process level risk assessments per ICH Q9 guidelines
Provides audit support – customer/regulatory /corporate, etc. as needed
Perform various risk assessments with a cross functional group
Participate in site Environmental Health and Safety, Performance Excellence, Lean, Quality Improvement Plans, and related initiatives designed to meet key business objectives
Preferred
Excellent written and oral communication and leadership skills
Ability to lead and influence people
Ability to work in and promote a team environment
Basic understanding of Six Sigma and/or Lean manufacturing tools
Complete understanding and application of principles, concepts, practices, and standards within discipline
Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations
Knowledge of US and International pharmaceutical manufacturing regulations
Experience using thermometric studies instrumentation (Kaye Validator/ValProbes/ Ellab)
Company
Endo
Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.
Founded in 1997Malvern, , US
1001-5000 employeesFunding
Current Stage
Late StageLeadership Team
Blaise Coleman
President and Chief Executive Officer
Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
Recent News
2025-09-23
2025-09-22
Company data provided by crunchbase