Job Overview
We're seeking a highly skilled professional to join our team as a Senior Associate. This role is ideal for individuals with a passion for quality oversight and a strong background in regulated manufacturing environments.
The successful candidate will be responsible for providing quality oversight for validation activities related to BioMarin's products and facilities, utilities, equipment (FUE). This includes supporting the development of validation plans for specific system implementation projects and reviewing/approving project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols).
Key Responsibilities:
* Provide quality oversight for FUE activities related to BioMarin's products and facilities, utilities, equipment (FUE).
* Support the development of validation plans for specific system implementation projects.
* Review and approve project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
* Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOPs.
* Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin.
* Lead and represent QA Validation in multi-departmental meetings & project teams.
* Identify and implement improvements to the QA Validation systems.
* Participation in the change control program for modifications to qualified systems.
* Quality oversight for the Revalidation Evaluation program.
* Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required.
* Apply a risk management approach to identify, categorize, prioritize, mitigate and establish contingency plans associated with qualification/validation and system risks.
Requirements:
* Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
* +3 years' experience in a cGMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems/validation.
* Organizational and management skills to coordinate multi-discipline project groups.
* Ability to speak, present data, and defend approaches in front of audiences and inspectors.
* Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
* Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.