• Ensures compliance by validating facilities, equipment, systems, and processes while authoring and approving commissioning and validation documents for sterile and non-sterile manufacturing.
• Manages the lifecycle of Computer System Validation, executes multiple protocols, and analyzes data to create reports, including deviations.
• Coordinates cross-departmental validation activities, tracks timelines and budgets, and drives technical transfers across sites.
• Leads continuous improvement through quality investigations, Corrective and Preventive Actions, Risk Assessments, Change Control, and staff training.
• Provides expertise during audits, manages contractors for Commissioning, Qualification, and Validation (CQV), and develops cleaning, sterilization, and process cycles.

• Bachelor of Science degree in a scientific or engineering discipline.
• 10 years Validation experience in the pharmaceutical or biotechnology industries.
• Advanced knowledge in current good manufacturing practices, CQV, sterilization validation, Good Automated Manufacturing Practice, 21 Code of Federal Regulations Part 11, and experience with Computer System and Cleaning Validation.
• Strong project management, problem-solving, and analytical skills with attention to detail and proficiency in Microsoft Office and Quality Management Systems.

• Customer Focus: Ability to build strong customer relationships and deliver customer centric solutions.
• Optimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvement.
• Collaborates: Builds partnerships and works collaboratively with others to meet shared objectives.
• Resourcefulness: Secures and deploys resources effectively and efficiently.
• Manages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problems.
• Ensures Accountability: Holds self and other accountable to meet commitment.
• Situational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situations.
• Communicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiences.

• People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growth.
• Quality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produce.
• Service: We are here to serve others. Every interaction with our patients, providers, employees, and other stakeholders comes from a place of service.
• Innovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical care.

Important Notice: Protecting Your Information
Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.