Automation Engineer 1/2, QA Validation
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
This position is responsible for equipment, facilities, and utilities automation qualification activities in a cGMP environment. The candidate should have a strong background in Automation Validation. This position will coordinate, validate, and manage projects related to equipment implementation and manufacturing process changes. The position will primarily focus on the validation needs of new implementations and changes, but will assist the users with equipment design documentation review and approval of User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Software Design Descriptions (SDD), Configuration Specifications (CS), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT)…), Automation Test Script (ATs), establishing acceptance criteria, and support regulatory agency assessments/reports. This position will be responsible for QA review of automation qualification documentation, serving clinical and commercial manufacturing facilities. Following validation, the position will assist with Regulatory document assessment and drafting, and with defending the work to regulatory agencies. The position organizes and performs qualification activities with minimal supervision.
- Provide automation activities project management oversight for new equipment implementations and process changes.
- Coordinate with users to map out requirements and specifications.
- Coordinate with Engineering to ensure that validation activities are appropriately planned to coincide with the overall project implementation.
- Review and approve automation validation documentation for qualification of equipment (supporting new process changes or large novel equipment implementations) including bioreactors, autoclaves, chromatography equipment, pressure vessels, filling equipment, etc. as well as facilities and utility automation qualification packages.
- Review and approval of URS, FRS, SDD, CS, FAT, SAT and AT documentation.
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentation of materials in regulatory inspections.
- Create SOPs/Guideline documents for implementation of automation qualification for both new and existing process changes.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and validation approaches and systems utilized at BioMarin.
- Represent Validation in multi-departmental meetings & project teams.
- Other duties as assigned.
- BS/MS in a technical discipline (physical, engineering or biological sciences preferred but not required).
- Training in project management preferred.
- 4-6+ years' experience in a cGMP regulated environment, with exhibited knowledge or proficiency in validation and change control.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections, with experience in presenting or defending departmental functions in audits and regulatory inspections.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications (such as Power BI a plus).
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for validation expectations. (Understanding of regulatory guidelines for other countries a plus).
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.