Matica Biotechnology is at the forefront of biopharmaceutical research and development. The Matica Bio team brings an average of 15 years of cell and viral vector manufacturing experience to the development and manufacture of advanced therapy products. At our purpose-built GMP facility in College Station, Texas, we provide rapid development and scale-up of cell and gene therapies, vaccines, and Oncolytics meeting worldwide regulatory compliance.
The true value of a CDMO is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We’re a cell and gene therapy CDMO powered by people, and our people provide real benefits to the quality, safety and speed of the cell and gene therapy development pathway. Our inventive thinking and foresight help us strategize the best path to take therapies from the lab to the market. Come join our dedicated team and Make it Happen With Matica Bio!
Position Opportunity:
The Validation Engineer I is an entry level position and will support the efforts of the Validation department.
How you will make an impact:
- Responsible for the creation & review of Commissioning, Qualification, Validation protocols and Reports.
- Responsible for the creation & review of Validation Risk Assessments and System Impact Assessments.
- Responsible for the execution of Commissioning, Qualification, and Validation protocols.
- Represent Department in Project Team meetings, as applicable.
- Serve as liaison with outside vendors as a representative of Matica validation team.
- Interact with Project Teams and Cross-functional groups.
- Address and/or escalate site compliance problems and issues to Management.
- Ensure compliance with appropriate internal and regulatory policies and procedures.
- Determine and develop Validation approaches and resolve complex Validation issues, working closely with cross functional teams to address deviations as well as recommend and implement corrective and preventative actions.
- Execute Validation projects and ensure adherence to schedule
- Communicate Validation requirements, timelines, and resource needs to Validation management
- Maintain Validation equipment and documentation to ensure organization and audit readiness
- Promote Quality culture across functions.
- Must be flexible and able to effectively manage multiple competing priorities.
- Perform other duties as assigned.
As a future Matican you bring:
Education
- Associates degree. Bachelor`s Degree in a Life Science, Engineering or related science discipline preferred.
Experience
- Entry level position. No experience required, but 1-2 years of direct job-related experience in GMP facilities is preferred.
Knowledge
Working knowledge preferred in the following areas:
- Aseptic practices and clean room operations.
- Temperature Mapping techniques. E-VAL Pro knowledge is a plus.
- Knowledge of cGMP and FDA regulatory requirements applicable to pharmaceutical manufacturing (including Cell/Gene/Viral therapy products). Knowledge of EMA regulations are a plus.
Skills
- Technical writing highly preferred
- Organization, multitasking, time management
- Verbal/written communication skills
Qualities & Attitude
- Must be capable of working independently and maintain a strong attention to detail.
- Must work with honesty and integrity. Engineering Ethics are a priority.
- Must be capable in working in a collaborative environment.
Competencies we look for:
Commitment to Excellence, Problem Solving/Decision Making/Analytical Thinking, Communication Skills, Teamwork/Cooperation/Supportiveness, Flexibility/Adaptability, Initiative/Taking Ownership, Focus on Safety, Ethical/Trustworthiness, Work Ethic/Reliability, Thoroughness, Customer Service
We Value:
Matica’s Values are at the forefront of everything we do, our culture, and the decisions we make.
- Start with Safety & Quality
- Choose the Path of Openness, Honesty, and Integrity
- Nurture Our Differences to Enable Our Collective Success
- Learn Continuously to Ensure Our Value and Relevance
- Commit to Delivering Life Altering Therapies
