Job Title: Senior Process Specialist
We are seeking a highly skilled and experienced process specialist to join our team. In this role, you will be responsible for leading and executing process gap analysis, facility fit studies, and process safety/risk assessments for new product introductions.
Responsibilities:
* Lead and execute process gap analysis, facility fit studies, and process safety/risk assessments for new product introductions.
* Develop and update critical NPI process documentation, including Transfer Plans, Protocols, Procedures, and Manufacturing Batch Records.
* Monitor and analyze process data during manufacturing to ensure robust process performance and compliance.
* Provide operational technical support and problem-solving for process-related issues, ensuring timely resolution.
* Assist in developing and optimizing manufacturing processes for the introduction of new products, collaborating with global science and quality teams.
* Prepare and maintain specifications for NPI materials and consumables to ensure quality and regulatory compliance.
* Lead or assist in product and process-related investigations, change plans, and continuous improvement initiatives.
* Support, supervise, and train operations personnel on NPI processes to ensure capability and compliance.
Requirements:
* Bachelor's degree in a relevant engineering, science, or technical discipline (essential).
* Minimum of 1-3 years experience in a similar process engineering role within pharmaceutical or biopharmaceutical industries.
* Strong technical and operational knowledge of unit operations within a fill-finish facility (essential).
* Proven problem-solving skills, attention to detail, and ability to work autonomously under pressure.
* Excellent communication and interpersonal skills, with demonstrated ability to lead and influence cross-functional teams.
Why Join Us?
At our organization, we empower individuals to excel because your contributions matter. Taking a skills-based approach, we provide opportunities for you to shape your career, maximize your impact, and grow professionally. By joining us, you'll engage in meaningful work that drives sustainable solutions for a better planet while leaving a lasting legacy.
Our Commitment to Equality, Diversity, and Inclusion
We are dedicated to creating an environment where everyone can thrive. Through our six ED&I workstreams Age, Disability, Faith, Gender, LGBT+, and Race we foster innovation by bringing together diverse perspectives. Together, we strive to improve quality of life while building a more inclusive future.