Lead Validation Eng

Requirements

• 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 ot

Benefits

Additional Information

Why Us? 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 MINIMUM REQUIREMENTS : Education: Bachelor's degree in a science/engineering related field is preferable with related technical background

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