Lead Validation Eng

Location: St. Louis

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.
** Job Description Summary
** The Lead Validation Engineer will create, review and/or execute primary qualification and validation activities for equipment, instrumentation, utilities, and manufacturing processes. The overall objective of the position is to ensure product quality and site compliance to regulatory requirements. The Lead Validation Engineer interfaces with Manufacturing, Quality Assurance, Quality Control, Engineering and R&D to obtain the process, equipment, controls, and installation support documents necessary for protocol development and review.
The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other validation activities as needed to support the Specialty Generics organization. Software systems may be local or hosted solutions. The candidate will also be responsible for the data integrity program, including management of assessments and implementations of associated mitigations for both laboratories and manufacturing.
** Job Description
**** ESSENTIAL FUNCTIONS/

SKILLS:

*** 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
** DEPARTMENT SPECIFIC/NON
- ESSENTIAL FUNCTIONS:

*** 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
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* MINIMUM REQUIREMENTS:

**
* Education:

* Bachelor’s degree in a science/engineering related field is preferable with related technical background

* Experience:

* 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.
* Preferred Skills/

Qualifications:

** 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.
*…