Valeant Pharmaceuticals

Validation Manager

US-FL-Tampa
Job ID
9577
Category
Operations
Pos. Type
Full Time

Overview

Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

 

Reporting to the Director of Engineering, the Validation Manager is responsible for oversight of the Validation Department Programs and related activities including: qualification and re-qualification of facilities, utilities, equipment, computerized systems, cleaning, disinfection, and process validation. A strong focus is on sterility assurance (validation of steam/dry heat/gamma/EO sterilization, media fill, and smoke testing). The scope includes all regulated areas of manufacturing. Additionally, the Validation manager is responsible for setting validation strategy, policies, and procedures. The Validation Manager liaisons with site employees and with other Bausch & Lomb sites, vendors and regulatory authorities to provide validation and project support, compliance guidance and industry best practices to adopt as B&L benchmarks.

 

 

Responsibilities

  • Responsible for providing strategic and tactical leadership for the Validation Department. 
  • Provide coaching, training and/or mentoring to Validation Engineers, Technicians, and Contractors.  Manage and develop the performance of direct reports by setting clear goals, providing timely performance feedback, recognizing and rewarding employees, and holding reports accountable.  Maintain staffing levels and meet approved hiring plans.
  • Development and oversight of the execution of validation related documents throughout the system, including development of a comprehensive validation master plan covering equipment, utilities, sterilization, cleaning, aseptic processing, cleanroom qualification, computerized system validation.
  • Plans, develops, implements, sustains and provides meaningful impact assessment for the site validation master plan, remediation assessments, validation strategy and tactical level qualification schedules.
  • Oversee validation functions including but not limited to media fills, new product / process validation, and cleaning validation.
  • Provide technical support and guidance on validation protocols, execution of protocols, and generation of final reports.  Review and oversee projects to ensure that the appropriate controls, approvals, and validation requirements are implemented.
  • Monitor projects through major milestones and completion. Provide and direct additional resources from supporting departments as needed to be successful in the implementation of projects. Communicate status of the validation system as required.
  • Conduct gap assessments as needed and provide action plans for resolution of any identified gaps.
  • Provide input to local change control board.
  • Utilize quality systems to measure, analyze, and improve the validation engineering system to ensure overall compliance and increased efficiency.
  • Interfaces with outside regulatory and legal authorities as appropriate.
  • Review, revise and approve procedures and specifications, and communicate and implement them with the department and operations.
  • Ensures discrepancies and excursions are fully investigated within the pre-established turnaround timeframe. As appropriate participate, write, coordinate and lead in nonconformance investigations and CAPA resolution in compliance with current agency and industry standards.
  • Ensure processes are in place for timely escalation of critical failures or discrepancies to the leadership of Operations, Quality Assurance, and owning departments.
  • Ensure Validation Quality System audit readiness at all times.  Represent the validation quality system and defend policies, program, and validation documentation during audits, regulatory inspections. Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed system, process, facility or procedure.
  • Ensure that the department maintains compliance with cGXP; ISO 9001; ISO 14644; CFR 11/210/211; Canadian Regulations SOR/98-282; Japan PAL/MO 169, 179; EU Guidance on Good Manufacturing Practice, including Annexes: 1, 11 and 15; GHTF; WHO; ICH; Guidance for Industry, Process Validation: General Principles and Practices FDA; USP Chapter <1058>; other standards, guidance documents and best practices as applicable
  • Ensures that validation personnel are performing, coordinating and planning validation events that are in compliance with stated safety requirements, OSHA and EPA requirements. 
  • Establish department budgets to meet strategic business plans

 

Direct Reports:

  • Yes - Validation Engineers, Validation Technicians, Validation Contractors.

 

Key Relationships: 

  • External regulators; Contract Customer Auditors;
  • Internal Team: Works with operations, Quality Systems, Quality Engineers, Laboratories and the MRB (as appropriate) to ensure sound and timely decisions are made regarding validation strategy, product impact, product release, overall risk analysis

Qualifications

  • Bachelor's Degree in Engineering with 8 years of experience in cGMP Validation in a Manufacturing environment, or Master's Degree with 6 years of experience in cGMP Validation in a Manufacturing environment.
  • Significant experience planning, deploying, managing and sustaining validation or technical service operations in a sterile dosage pharmaceutical facility.
  • Experience in change requests, change control, leading, conducting and writing investigations.
  • Experience with automated quality documentation systems (e.g. CQMS, Change Control, Documentum)
  • Experience as direct interface with FDA and other external regulators during inspections.
  • Demonstrated strong understanding of Quality systems

 

Be Aware of Recruiting Fraud

Valeant is an EEO/AA employer M/F/D/V.

 

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

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