As a key member of our biopharmaceutical team, you will play a vital role in ensuring the quality and compliance of our manufacturing processes. This 6-month contract position offers an opportunity to plan and execute qualification activities across facilities, utilities, equipment, and processes.
Key Responsibilities:
* Develop and implement qualification and validation plans that meet industry standards and regulatory requirements. Execute testing protocols and review reports to ensure compliance with cGMP and company procedures.
* Collaborate with cross-functional teams to maintain the validated state of equipment and processes. Ensure all duties are performed in accordance with GMP requirements, SOPs, and controlled documents.
* Be flexible to take on additional tasks and responsibilities as requested. Demonstrate expertise and leadership in validation and act as a role model for the organization.
Essential Requirements:
* A bachelor's degree qualification in an engineering or science discipline is required.
* Minimum of 3-5 years' experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT, or engineering function.
* Experience in commissioning and qualification/validation of facilities, utilities, equipment, and instruments. Maintenance of the validated state, requalification/revalidation, and troubleshooting of technical issues.
* Proven track record of providing technical solutions for GMP manufacturing operations and equipment in a biologics processing environment.
* Effective communication skills and ability to coordinate system design and vendor packages.