Who We Are

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

About Technical Operations

Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

QA Validation Associate

12 month Contract

SUMMARY DESCRIPTION
BioMarin are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
This position is responsible for the quality oversight of validation activities in a GMP regulated environment, incorporating implementation, requalification and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.

RESPONSIBILITIES

Provide quality oversight for validation activities related to BioMarin’s products and facilities, utilities, equipment (FUE).
Support the development of validation plans for specific system implementation projects.
Supporting and reviewing/approving (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.
Support validation policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
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.
Identifies and implements 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, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risks

EDUCATION

Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

EXPERIENCE

+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.
Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
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.
Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.

CONTACTS
This position will require interaction with multiple levels (from technicians up through Sr. Management) in Engineering, Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources.

SUPERVISOR RESPONSIBILITY
There are currently no direct reports to this position.

~~Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

QA Validation Associate

Job Description