Job details
Job type full-time
Full job description
Biomarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseasesWe target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are childrenThese conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment optionsBiomarin 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 marketThese 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 patientsCome join our team and make a meaningful impact on patients’ lives.
Title: principal packaging engineer, global external operations
Location: 100% remote, or novato, ca, or shanbally, ireland
Duties
Collaborate with internal groups and cmos to ensure successful on-time packaging introduction, which includes package testing, artwork approval, overseeing machinery iq, oq, and pq, and ensuring compliance with specifications and regulatory guidelines.
Determines the functions most critical to departmental success and proactively engages these to drive business forward.
Can lead multiple components of departmental strategic initiatives.
Provides technical guidance and training to junior group members.
Examines and works to resolve inter-departmental working issues from a broader organizational perspective.
Analyzes, revises and develops internal procedures and systems required to ensure gmp compliance.
Manages complex processes across functions and interacts effectively with the other team members to ensure product meets regulatory, performance, and cost requirements.
Leads technical investigations and assessment of deviations.
Advises more junior staff or members of project teams in the initiation and execution of new methods, considering economic, regulatory and safety factors
Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
Makes recommendations for cost reduction initiatives as related to materials, labor or overhead.
Makes recommendations for continuous improvement in all operation processes.
Investigates the feasibility of applying advanced principles and techniques of related engineering specialty to products and problems.
Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes.
Manages budget for packaging engineering-related projects and activities.
Manages team of personnel, including hiring, organizing and/or conducting training, conducting performance reviews, and ensuring assigned work is performed to required standards.
Works independently on significant portions of projects.
Manages activities at internal and cmo sites, including providing project timelines, resolving issues, on-site troubleshooting, and providing overall technical support; may negotiate pricing for defined projects.
Coordinates the specification, installation, utilization, qualification, and improvement of equipment used for biomarin products.
Approves documents for regulatory filings, and reviews filings, including sections from other disciplines.
Identifies bill of material components for company products.
Knowledge & skills
In-depth knowledge of good manufacturing practices (gmps)
In-depth knowledge of manufacturing principles, concepts, industry practices, and standards
Strong computer, organizational, and management skills required.
Excellent verbal, written and interpersonal communication skills are required.
Maintains full working knowledge of state-of-the-art principles and theories, applying such knowledge to the direction that supports biomarin’s interests.
Demonstrates technical proficiency and creativity, collaboration with others and independent thought in suggesting new methods, processes, etc.
Must think critically and creatively, and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
Education.
10+ years of experience in the pharmaceutical industry or medical device industry and a bs or ba
8+ years of relevant experience and a ms.
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.
