Lead Validation Eng

Endo•Saint Louis, MO

19h•Hybrid

About The Position

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.

Requirements

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.
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)
Focus, Drive for Results, Managing Through Systems, Written Communication, Customer Focus, Listening, Organizing, Comfort around Higher Management, Multi-tasking, Prioritization, Risk Based Decision Making, Managing Diversity, Motivating Others
Directly and indirectly works with colleagues in other groups; including Manufacturing, Operations, Quality Control, Engineering, and R&D to achieve key operational objectives.
Interacts with IT, site Business Owners, Technical leads.
Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs.
Need to interact effectively with others throughout the organization to complete Data Integrity assessments and implementation of applicable mitigations.

Nice To Haves

Basic understanding of LD50/HBEL derived maximum carryover limits
Familiar with Development, QA and Production environment terminology and testing strategies.
Familiar with data integrity guidance from MHRA and FDA

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.
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.
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
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