Sr. Engineer 2 Asset Quality

Location
Novato, California
Posted
Nov 06, 2018
Ref
14371
Required Education
Bachelors Degree
Position Type
Full time
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.   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 asset maintenance, calibration, reliability, decommissioning, and replacement. The incumbent will have three major areas of responsibility; 1) Collaborate with the Engineering, Facilities and Manufacturing teams in supporting reliability and uptime efforts, 2) Provide Quality oriented expertise with equipment Failure Modes and Effects Analysis (FMEAs) on equipment and utility systems to identify and address high-risk failure modes, and 3) Support Engineering and Manufacturing to establish standards and processes that ensure equipment remains in an operational state with minimal downtime.  As the Quality organization's asset reliability SME (Subject Matter Expert), play a key role with the maintenance and reliability communities of practice to institutionalize lessons learned and best practices. RESPONSIBILITIES •            Monitor and assess impact to BioMarin's Quality System of all government regulations, guidance, and expectations as they pertain to asset maintenance and reliability. Through partnering with internal and external engineering teams, share this information to increase the collective understanding and implication of these changes. •             Collaborate with Engineering to implement a reliability-based maintenance program for assets to ensure the spare parts inventories are appropriate to support manufacturing and prevent unplanned downtime. •             Approve procedures (SOPs) and specifications for the reliability engineering and maintenance aspects of existing and new equipment and utility systems •             Approve the analyses of equipment/processes and identify areas for improving reliability and efficiency •             Collaborate with Facilities and Engineering personnel to ensure that a reliability-based approach is adopted in maintenance activities. •             Contribute to projects related to equipment, utility and facility improvements to system reliability •             Provide Quality requirements for reliability maintenance input into engineering design to ensure system reliability and minimize lifecycle costs •             Execute change control including writing and executing change control test plans •            Ensuring alignment of processes, procedures and methods across multiple organizations (internal and external). •            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. •            Author and review relevant (facilities, utilities, equipment, automation) 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. •            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, Facilities, Regulatory, MSAT, Manufacturing and other functions, this position delivers a Quality Policy and associated standards that enables efficient and effective execution of asset maintenance and reliability programs throughout the network.  The Asset Quality Lifecycle team will be a major driver for Quality efficiency, and will highly impact operational costs by ingraining quality into 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: •           5 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.  8 years of asset reliability experience 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 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, Facilities, 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.  ~BIO