Description
POSITION
Sr. Engineer 1, Global Process Validation
SUMMARY DESCRIPTION – Sr. Engineer 1, Global Validation-Process
This position reports to the Manager/Sr Manager of Global Process Validation and is responsible for process validation activities in a cGMP environment. This position will coordinate and manage process validation projects related to the implementation of new manufacturing processes and changes to existing processes according to the three phases of process validation. Process validation activities may include drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, packaging, shipping, and completion of validation risk/impact assessments and evaluations, etc.
The position organizes and performs process validation activities with general supervision within a cross-functional cGMP environment while fostering a collaborative Team environment. Other responsibilities of this position include project management, protocol generation, protocol execution, final summary report generation, CTD module generation and review, and other duties as assigned.
Across BioMarin, we strive for an organizational culture where employees trust the people they work for, have pride in what they do, and enjoy the people they work with. At BioMarin, we believe in Innovation. Through Inclusion. We are committed to creating a workplace of belonging through its Diversity, Equity, and Inclusion efforts and believe that by being our best, authentic selves, we can create rare opportunities and personal impact for each other and for our patients.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. This includes creating a work environment that retains and attracts under-represented talent and improving the employee experience for women and the under-represented. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
In this role specifically, in addition to the DIAL attributes (Decision Making, Influence, Agility, and Leadership) we expect all our people managers and technical leaders to create a psychologically safe (note, psychological safety is a belief that one will not be punished or humiliated for speaking up with ideas, questions, concerns, or mistakes) place for everyone across all teams.
Key words: validation; process validation, drug substance, drug product, aseptic filling, mixing, chromatography, science, protocols, reports, biologics, small-molecules, gene therapy, advanced medicine
RESPONSIBILITIES
- Perform process validation activities related to BioMarin’s drug substance and drug products, through defined clinical and commercial stages.
- Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgment within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet BioMarin and Health Authority requirements.
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
- Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
- Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures.
- May participate on sub-teams.
- Gain knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
- Participate in multi-departmental meetings & project teams.
- Identifies and assists with implementation of improvements to Process Validation systems (department level impact).
- Generation of process validation master plans, core validation master plans and additional supporting documentation.
- Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal BioMarin laboratories.
- Coordination of process validation activities involving cross-functional, multi-departmental teams including Manufacturing (contract), Manufacturing Sciences, Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- Other duties as assigned
SCOPE
The candidate will have a significant role in the approval of documentation and support for release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives. Decisions made by this position can significantly affect project timelines and the ability to manufacture drug substance/drug product meeting BioMarin and Health Authority requirements.
EDUCATION
Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Training in project management is preferred
EXPERIENCE
- 6+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- 2+ years experience in a position utilizing formal project management a plus.
- Organizational and management skills to participate in multi-discipline project groups
- Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
- Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
- Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations.
- Proficiency with technical writing expected.
- Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications is highly beneficial.
Hybrid/Flexible Role
Flexible Work arrangement with at least two days onsite every week
WORK ENVIRONMENT / PHYSICAL DEMANDS
This function will perform majority of work in an office setting, reviewing documents, participating in meetings, authoring documents. This function may perform up to 60% of its functions at a computer terminal.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; high pressure and temperature utility systems, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The ability to perform gowning activities and enter the manufacturing plant is preferred, but not required.
EQUIPMENT
This position requires ability to utilize a computer to perform tasks.
CONTACTS
This position will require interaction with multiple levels (from technicians up through Sr. Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Technical Development, Facilities, Regulatory Affairs, Accounting, and People Resources.
SUPERVISOR RESPONSIBILITY
Position has no direct reports at this time.
CAREER DEVELOPMENT
Demonstrated proficiency and experience in developing and maintaining validation department within cGMP expectations for the manufacture of drugs at BioMarin.
Demonstrated proficiency and experience in maintaining and defending validation systems satisfying regulatory inspection scrutiny
Demonstrated proficiency and experience in managing projects requiring multi-departmental coordination.
Demonstrated experience and knowledge of multi-departmental functions and issues (understanding the organization).
Successfully achieving project goals and meeting company deadlines in timely and cost-effective manner.
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.
Who We Are
BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.
Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
Our Culture
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.
