Engineer 1/2, QA Global Validation CSV
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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.
The Engineer 1 or 2 QA Computer System Validation reports to the Manager of QA CSV and is responsible for ensuring the Information Management (IM) and Quality Assurance (QA) departments are compliant with all applicable regulations including FDA’s GLP, GCP and GMP/Part 11 and EU Annex 11 and industry guidelines like ISPE GAMP5 and PDA. The Engineer 1 QA CSV, will also ensure all computer systems follow a lifecycle approach and are evaluated, selected, implemented, and maintained in compliance with the applicable regulations (GLP, GCP, GMP) and IM and QA Biomarin SOPs. The incumbent will have three major areas of responsibility; 1) work in accordance TOPS and Quality Global vision and standards, 2) partnering with BioMarin’s IM, QC, Dev Sciences, and engineering teams to support IM Portfolio projects and systems CSV lifecycle deliverables, and 3) partnering with the QA CSV Validation team to ensure team work and meet group goals.
- Provide oversight of Enterprise and QC Analytical Instrument computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.
- Provide guidance on CSV validation issues and discrepancies. Support investigation of CSV defects and quality records (Deviations, CAPAs).
- Provide guidance and QA oversight for SDLC documents like User Requirements, Specifications and Validation/Qualification protocols and test scripts.
- Responsible for the authoring and development of Periodic Reviews Reports for computerized systems across BioMarin.
- Provide quality oversight to support and follow BioMarin’s Data Integrity Program.
- Establish and sustain BioMarin’s computer system validation global policies and standards that incorporate industry best practices and are health authority compliant.
- Partnering with internal and external IM, QA and Development Sciences teams; sharing information to increase the collective understanding of QA and Data Integrity programs.
- Knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, ISPE GAMP5, as it relates to systems used at BioMarin.
- Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external).
- Authoring and /or revising SOPs.
- Authoring and / or revising validation documents and protocols.
- Administer applicable electronic systems.
- Assist as needed in audits and inspections.
- Contribute to projects related to QA CSV improvements and system reliability.
- Development, execution and approval of change control records.
- Support the Compliance team on computerized system audits to ensure compliant vendor/supplier management program and services.
The work product from the Engineer 1 or 2 QA CSV will directly support BioMarin processes and health authority compliance. Partnering with the QA CSV team, Engineering, Regulatory, Manufacturing, QC, site QA and other functions; this position delivers a QA CSV oversight output that enables efficient and effective execution of the computer validation lifecycle at BioMarin. This individual contributor and team player will be supporting CSV Quality efficiency, and will ingrain quality into the Information Management group.
- BA, BS or MS degree in a scientific, information systems or engineering discipline.
- Master degree in Science or Business, Project Management Certification, Quality Engineer Certification.
Required Experience and Abilities:
- 5+ years of experience in CSV for pharmaceutical, biotechnology and/or medical device manufacturing equipment, automation, processes and facilities including experience managing others.
- Highly motivated and flexible; Adaptable to a fast-paced, changing environment requiring effective interpersonal, partner-facing and teamwork skills in.
- Demonstrated knowledge of CSV, Electronic Records/Electronic Signatures, CFR Part 11 and Annex 11 principles in the biotechnology or pharmaceutical industry.
- Knowledge of various computerized systems, including but not limited to: QC analytical instruments, enterprise systems, automated process equipment and clinical data management software in the biotechnology or pharmaceutical industry.
- Well-developed computer skills and fluent with Microsoft Office applications, Oracle, TrackWise, LIMS and CMMS. HP Application lifecycle management (ALM) system knowledge a plus.
- Ability to function and contribute as part of a team and contribute to team-based decisions.
- Project management skills savvy.
- Ability to think critically, and demonstrate troubleshooting and problem-solving skills and decision making.
- Ability to function efficiently and independently in a changing environment.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
WORK ENVIRONMENT / PHYSICAL DEMANDS
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
Due to the global organization, the employee may be required to participate in meetings outside of local working hours. The employee will be required to travel internationally approximately up 10%.
Standard office workstation and desk equipment.
IM, Compliance, Engineering, Development Sciences, Regulatory, Quality, Global Supply Chain, Compliance, TOPS Program Management Group, BPI/BPE, HR.
Refer to Responsibilities section; Consistent track record of exceeding objectives and supporting continuous improvement within area of influence. Depending on experience, the candidate may be eligible for another Engineer role at QA Global Validation.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.