Seagen

Site Engineering Director

Description

Summary:

Seagen is seeking a Site Engineering Director role to serve as the Real Estate & Facilities (REF) site Engineering leader within a new planned manufacturing facility. In addition to supporting the design of this new facility, the role will have overall site responsibility for site Engineering, Maintenance, Calibration, associated contract services, management of the departments operating budget and the capital budget to support all site functions. This function will be an integral Partner to the site Technical Operations organization to ensure facility, utility and related equipment availability to achieve commercial targets. This engineering lead function will possess strong engineering capability, problem solving techniques, business acumen and broad focus within industry to drive decision making for business value add. This role will require effective communication of the organization strategy to drive cross functional and departmental alignment. This role will report the Sr. Director of Engineering, Center of Excellence. The expectation is this function will set a target for “Best in Class” results while focusing on quality product for Seagen patients.

Principal Responsibilities:

• Responsible to oversee the operation and maintenance of the physical plant, including equipment and facility maintenance, testing, troubleshooting, calibration and repair of all buildings and equipment at the site
• Lead responsible and accountable for site capital plan, managing technical, maintenance, and automation teams while ensuring alignment with Corporate EHS, Quality and Compliance for site operations support
• Establish and manage risk management and escalation process to ensure proactive measures are taken to reduce impact or risk to Seagen - EHS, Quality, Compliance, Security, Operations, Facilities, or REF
• Use Quality Management Systems, QMS, to manage department Change Control, Deviation, and CAPA records
• Working with the site leadership management team, to develop and implement long-range facilities plan to reach objectives, and ensures that tactical facilities decisions are consistent with this plan
• Is a member of and participates in establishing strategic plans and objectives, on administrative or operational matters and ensuring effective achievement of objectives
• Responsible to monitor utility consumption and ensuring facility and utility systems, including water purified for use in manufacturing meet the standards required by the FDA and cGMPs
• Responsible for directing the management of the outside contract services for the Everett manufacturing facility (e.g. custodial, landscaping, etc.). Responsible for managing the validation of all facilities and utility systems
• Responsible for supporting all quality and regulatory audits at the site and ensuring compliance within the Engineering Department. Responsible for the management and development of direct and indirect reports
• Responsible for employee management and development and a key member of the REF Engineering Center of Excellence (COE) Leadership Team and Governance
• Responsible for the design and modifications of all facilities on site
• Responsible for ensuring all staff complete all training requirements and maintaining 100% compliance with all assignments
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions
• Responsible for performing additional related duties as assigned
• Participates in establishing strategic plans and objectives, on administrative or operational matters and ensuring effective achievement of objectives
• Leads the development of the Maintenance program for site
• Identify and support innovations by implementing new technologies which drive growth and process improvements using digital data and analytics (DD&A) such as Power BI
• Ensures adherence to Seagen Data Integrity principles
• Ensures compliance against local, state, federal, country and industry requirements
• Ensures accountability for site Safety Culture
• Site Engineering Director and point of contact for planning, technical design, construction, commissioning and validation support for site related projects and shutdown activities
• Contribute to the REF Engineering Talent pipeline by driving organization development of site engineers technical capability and competency with intent to build an overall succession plan

Required Qualifications:

• Professional Licensed/Registered Mechanical, Chemical Engineer or Electrical Engineer, PE
• 10+ years experience and progressive experience with 7+ in management of technical staff within GxP environment – pharmaceutical, biotechnology or biologic industry
• Bachelor’s Degree in Electrical, Mechanical, Chemical Engineering, Engineering / Technology related from an accredited university
• 5+ years experience in a Plant Facility Maintenance or Operations function agement Certification (PMP) is a plus

Preferred Qualifications:

• Experience use of Computer Maintenance Management Systems, CMMS
• Understanding of aspects for Commissioning and Qualification activities
• Ability to influence and persuade cross functional groups
• Transformational Leadership skill sets
• In depth knowledge of FDA, EMA, GxP and ICH regulatory requirements
• Broad communication skills and demonstrated experience in financial management and understanding of business value drivers are required
• Proficient use in MS Office as well as discipline-specific and project management software applications
• Familiarity and ability to work with instrumentation/calibration specialists in support of automation systems
• Ability to build effective cross functional / department teams and drive decision making
• Ability to work on-call rotation for the New Manufacturing site
• Master’s Degree in Engineering, or related field
• Lead Member, Membership within External Industry Organization
• International Professional Work Experience

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

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Seagen

Seagen is an Equal Opportunity Employer

Submitted: 04/02/2021