Skip Navigation

Sr. Engineer 2, Asset Quality

Location Cork, Ireland
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 Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. 

SUMMARY DESCRIPTION

The Sr. Engineer 2, Asset Quality reports to the Associate Director of Asset Quality Lifecycle and is responsible for setting the global Quality requirements and standards for materials of construction and manufacturing system hygienic design, cleanability, and steamability. The incumbent will have three major areas of responsibility; 1) establishing & sustaining BioMarin’s Materials-of-Construction (MOC)Hygienic Asset Quality requirements, 2) partnering with BioMarin’s engineering teams to improve manufacturing asset reliability in terms of cleaning, steaming, bioburden control, and corrosion control, and 3) partnering with the Global Process Validation and Manufacturing Sciences teams to ensure that MOC and cleaning and sanitizing processes are robust and compatible with associated manufacturing systems.  As the Quality organization’s hygienic design SME (Subject Matter Expert), play a key role with the Cleaning/Steaming and Materials communities of practice to institutionalize lessons learned and best practices.

RESPONSIBILITIES

•            Establish and sustain BioMarin’s cleaning, sanitizing, and sterilizing global policies and standards that incorporate industry best practices and are health authority compliant.

•            Monitor and assess impact to BioMarin’s Quality System of all government regulations, guidance, and expectations as they pertain to hygienic design and MOC. Through partnering with internal and external engineering teams, share this information to increase the collective understanding and implication of these changes.

•            Maintain current knowledge of industry standards related to MOC and Hygienic design as it relates to products developed and manufactured by BioMarin.

•            Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external).

•            Assessing MOC selection and cleaning/sanitizing processes effectiveness and efficiency.

•            Monitoring Asset Performance over time.

•            Ensuring systems are fully implemented and integrated with other quality management systems, site and global engineering functions.

•            Developing and providing tools to enable system understanding across multiple organizations.

•            Leading continuous improvement initiatives based on user feedback, asset monitoring results, observations and responses.

•            Development and reporting of asset cleaning performance and reliability metrics.

•            Author and review relevant (cleaning, bioburden control) technical sections of regulatory submissions.

•            Authoring and /or revising SOPs.

•            Administer applicable electronic systems.

•            Assist as needed in audits and inspections.

•            Interacts with senior internal personnel and external partners on significant matters often requiring coordination across facility locations.

•            Serve as senior Subject Matter Expert on CQV issues/hot topics, with ability to identify and present to an industry audience current areas of concern and/or interest - remaining current with changing process, technology, and regulatory developments.

•            Collaborate with the Engineering, Facilities and Manufacturing teams in supporting reliability and uptime efforts.

•            Provide hygienic design expertise for utilities and manufacturing systems with a focus on aseptic operations, bioburden control, and cleanability.

•            Contribute to projects related to FUE improvements and system reliability

•            Execute change control including writing and executing change control test plans



SCOPE

The work product from the Sr. Engineer 2 Asset Quality Lifecycle will directly support capital spend efficiency and health authority compliance.  Partnering with Engineering, Regulatory, MSAT, Manufacturing and other functions, this position delivers a Quality Policy and associated standards that enables efficient and effective execution of MOC and cleaning/sanitizing/sterilizing programs throughout the network.  This Leader and team will be a major driver for Quality efficiency, and will highly impact operational costs by ingraining quality into Hygienic Asset Lifecycle Management.



EDUCATION

Required Education:

•            BS or MS degree in Industrial Engineering, Chemical Engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or equivalent.

Preferred Education:

•            CQE (ASQ Certified Quality Engineer), PMP, CRE (ASQ Certified Reliability Engineer)



EXPERIENCE

Required Experience and Abilities:

•            8+ years of experience in CQV for pharmaceutical, biotechnology and/or medical device manufacturing equipment, automation, processes and facilities including experience managing others; Computerized Systems                     Validation (CSV) experience a plus.  Five 5+ years of experience in capital delivery or Hygienic Design Engineering role in the pharmaceutical, biotechnology or other FDA-regulated industry.

•            Prerequisite knowledge, skills and abilities, as well as business acumen, to effectively build high performing partner relationships and successfully manage multiple projects.

•            Highly motivated and flexible; Adaptable to a fast-paced, changing environment requiring effective interpersonal, partner-facing and teamwork skills in.

•            Demonstrated knowledge of MOC compatibility, corrosion control and hygienic engineering principles in the biotechnology or pharmaceutical industry

•            Knowledge and expertise with process equipment in the biotechnology or pharmaceutical industry

•            Knowledge and expertise with clean room air-handling units, HEPA filtration, VHP sterilization, ISO classifications and differential pressures

•            Knowledge and experience with biotechnology or pharmaceutical industry utility systems (e.g. compendial water systems, compressed gases and liquid nitrogen)

•            Advanced ability to read and interpret drawings such as PFDs, P&IDs and electrical schematics

•            Well-developed computer skills and fluent with Microsoft office applications and CMMS. CADD experience is a plus

•            Ability to function and contribute as part of a team and contribute to team-based decisions

•            Ability to think critically, and demonstrate troubleshooting and problem solving skills

•            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

Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.



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.



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 15-20%.



EQUIPMENT

Standard office workstation and desk equipment



CONTACTS

Manufacturing, MSAT, PD, Engineering, Contract Manufacturing Operations (CMO), Regulatory, Quality, Global Supply Chain, Compliance, TOPS Program Management Group, IM, Strategy Realization,  BPI/BPE, HR



CAREER DEVELOPMENT

Refer to Responsibilities section; Consistent track record of exceeding objectives and leading continuous improvement within area of influence.  Depending on experience, the candidate may be eligible for another leadership role 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.

About our location

Cork

View

Hiring Insights

View
We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
Return to the top of the page