Sr. Specialist, Manufacturing Quality Validation

Role Summary

Sr. Specialist, Manufacturing Quality Validation. Primary responsibility for the Quality oversight and overall approval of validation and engineering change management activities. The Validation engineering department will support the implementation of the Validation quality program, and will independently manage 5+ key projects simultaneously.

Responsibilities

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
• Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
• Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
• Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
• Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
• May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
• May lead, author, or review investigations and implementation of preventive and corrective action

Qualifications

• Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
• 6+ years of overall experience in Manufacturing and/or Packaging, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
• Strong verbal and written communication skills
• Solid problem solving and analytical skills
• Solid interpersonal skills, including ability to negotiate/influence without authority
• Ability to manage complex projects and multiple projects (5+) simultaneously
• Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred

Skills

• Quality systems conformity
• Validation, engineering change management
• Regulatory compliance knowledge (cGMP)
• Project management
• Analytical and problem-solving abilities

Education

• Bachelor's Degree in Biology, Chemistry, Engineering or related field