Lead Validation Engineer

Job Title

Lead Validation Eng

Requisition

JR000015194 Lead Validation Eng (Open)

Location

St. Louis, MO

Additional Locations

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

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. 
• 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)

COMPETENCIES:

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

RELATIONSHIPS WITH 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.

PHYSICAL/VISUAL ACTIVITIES OR DEMANDS:

• Exert a negligible amount of force continuously and up to 20 pounds of force occasionally to lift, carry, push, pull or move objects.  Involves sitting, walking, and standing, reaching, talking and hearing.
• Flow of work and character of duties involve normal mental and visual attention much or all of the time.

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Reports to the Manager Quality Validation. Must be self-directed to manage validation activities (local and remote sites). Operates independently under limited supervision. 

WORKING CONDITIONS:

• 80% office environment which includes sitting for long periods of time and computer use.
• Less than 10% manufacturing environment exposure including temperature, noise, chemical or potent compound exposure.
• Less than 10% of laboratory exposure to plant products, solvents and reagents, some of which are hazardous or potent compounds

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.