Validation Engineer II

POSITION OVERVIEW:
The Validation Engineer II ensures compliance and operational excellence by managing validation processes across sterile and non-sterile manufacturing. It oversees multiple projects, develops documentation, and collaborates with teams to enhance efficiency, support product development, and drive continuous improvement aligned with our mission to provide high-quality, accessible medications.

ESSENTIAL JOB FUNCTIONS:

• Manages the full lifecycle of Computer System Validation, qualifying facilities, equipment, and processes, and developing key validation documentation, including Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Performance Qualification, and Process Qualification for sterile and non-sterile manufacturing.
• Oversees multiple validation projects, ensuring timely budget-compliant completion while driving continuous improvement to boost manufacturing efficiency.
• Prepares, reviews, and approves technical documents, including Standard Operating Procedures and current Good Manufacturing Practice (cGMP) records, while managing change control, Corrective and Preventive Action, and quality investigations.
• Operates and manages critical equipment, executing cleaning, sterilization, and lyophilization cycles.
• Provides training, supports Research and Development and product development, manages contractors for Commissioning, Qualification, and Validation (CQV) activities, and assists with audits to ensure compliance.

QUALIFICATIONS:

• Bachelor of Science degree in a scientific or engineering discipline.
• 7 years Validation experience in the pharmaceutical or biotechnology industries.
• Advanced knowledge of cGMP, CQV, sterilization process validation, and regulatory compliance, including Good Automated Manufacturing Practice and 21 Code of Federal Regulations Part 11.
• Strong problem-solving, project management, and attention to detail, with proficiency in Microsoft Office Suite, Quality Management Systems, and experience in Computer System Validation and Cleaning Validation preferred.

KEY COMPETENCIES:

• 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.

VALUES:

• 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.

SUPERVISORY RESPONSIBILITIES:
This position does not have supervisory responsibilities.

CERTIFICATES, LICENSES, REGISTRATIONS:
Certified Quality Engineer Preferred.

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 View email address on click.appcast.io.