Sr. Manager, Validation

Sr. Validation Manager

Bedford, Ohio

Full-time

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Validation Manager to join our team. In this role, you will be responsible for the Validation Master Plan (VMP) and managing qualifications and re-qualifications. This includes the review and approval of validation protocols, reports, and related documentation such as:
User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as well as Re-qualification (RQ) of process equipment, facility equipment and utility systems. Responsibility encompasses completion of validation activities that meet the requirements of the cGMP's as well as the pharmaceutical industry standards and comply with site validation policy.

• Coordinate and maintain critical validation responsibilities such as planning, scheduling, identifying resource requirements (people and equipment), coordinating with other departments, and ensuring compliance with applicable VMPs.
• Provides input to, reviews and approves User Requirements Specifications (URS).
• Review and approves protocols including Cycle Development Protocols, Investigational/Engineering Study Protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
• Provides input to Engineering on the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and Commissioning protocols.
• Researches equipment and processes, and establishes parameters and methods to test equipment to meet validation requirements.
• Ensures an effective coordination of the execution of qualifications and all aspects of the validation project with other departments, including but not limited to:
  Operations, Engineering, Quality Control and Quality Assurance.
• Ensures that the execution of protocols and all related documentation is in compliance with current Good Documentation Practices.
• Ensures equipment used for qualification purposes is properly maintained and calibrated.
• Supports and participates in change control process for critical system/equipment updates and repairs performed through the Work Order control mechanisms. Fully understands the requirements of each change control procedure.
• Assists in equipment troubleshooting and the use of problem solving techniques to resolve issues that could impact the validated state of equipment.
• Performs other duties as assigned and required.
• Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21
  
  CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

• 8-10 years of validation experience in the pharmaceutical or other GMP-regulated industry
• Experienc…