Executive Director Engineering Center of Excellence
Seattle Genetics in Seattle, WA
- Industry: Executive Management - Engineering/Production
- Type: Full Time
- Compensation: $95,870.00 - 143,270.00 / Year*
Executive Director Engineering Center of Excellence (COE)
Facilities & Engineering Bothell, Washington
Seattle Genetics is seeking anExecutive Director, Center of Excellence (COE) for Engineering. In this newly created function, the role will have the responsibility for developing a global engineering strategy aimed at mitigating risks,assure that facilities equipment and systems are designed, operated and maintained in a safe and compliant manner. Thefunctionwill provide capability to all our sites in the key areas of site technical authority, technical support, validation, oversees the lifecycle project portfolio through engineering policy, standards, and governance. Technical support refers to the engineering and problem-solving support for our sites and strategic engineering direction to achieve safety and compliance targets.
This function willalso oversee a capital Project Management Office (PMO) to ensure capital projects are delivered cost effectively and according toagreedupon scopes, budgets and schedules, manage site capital plan and ensure alignment with strategies. Thisperson will possess strong business and engineering acumen and perspectives combined with broad management and commercial skills, and an ability to bring a strategic focus to the function and be capable of adding value to the business. The role will report to the VP, Real Estate & Facilities (REF) and will collaboratewith Technical Operations (TOPS) to provide strategic engineering input into product development and manufacturing in line with network supply strategy. Further, the role will be accountable for maintaining engineering expertise and competency across sites.
- Establish and manage the Engineering COE function within the REF organization and define engineering strategies needed to meet global facilities and supply chain network goals.
- Oversight of development and implementation of engineering management system to ensure designs are compliant withSeaGenand other industry benchmarks and guidelines and with applicable regulations (e.g. ASME, FTA/EMA and other agency regulations, cGMP, HSE, etc.) while meeting business needs of timeliness and economy
- Establish and implement engineeringTechnical Authority (TA)ensuring engineering technical decisions, which impact design, operations, and maintenance of plant, equipment and systems are taken by personnel who possess appropriate technical competency
- Define and implementengineering standards (ESs),whichare uniform engineering or technical criteria, methods, processes and practices. The documents prepared by a professional engineering (PE) group or committee which will be the minimal proper engineering practices which ensure legal and regulatory requirement
- Develop an effective and implementReliability Based Maintenanceprogram to ensure the reliability of equipment, safety of employees, and product quality. This includes definingequipment criticalityanalysis program and that direct and indirect impact systems have a suitable and robust maintenance, servicing or monitoring plan
- Establish spare parts assessments understanding thespare parts criticalityand stocking policy
- Lead the Program Management Office through the ability toinfluence, motivate, and enable an effective,integrated capital project procedural framework that ensures cost-effective delivery and transparency of controls, clear accountabilities and responsibilities
- Provide capital projectsdesign and construction oversight & governance in compliance with global standards (e.g. ESs, EHS, QMS etc.) and local legal and regulatory requirements
- Provideexpert technical engineering adviceon request to all sites. Co-ordinate approach across sites on specific selected issues or programs. Respond tosignificant engineeringissues which have been escalated from site
- Implement independent business monitoring (IBM) and audits to ensure compliance with engineering and safety standards across the sites. Follow-up and provide supportfor closure of risks and corrective actions preventative actions (CAPAs) arising from audits, alerts, etc. at sites
- Bachelors degree in Engineering required, preferably Chemical or Mechanical Engineering
- Minimum of 10years experiencein a pharmaceutical operation with specific experience in these areas: technical services/engineering, supply chain, manufacturing operations including familiarity with regulatory compliance
- 8+ years of increasing responsibility in managing and leading a team of process development engineers and manufacturing teamswith proventrack record in operational management in a pharmaceutical, biotechnology, or biological industry
- Minimum of five years of project managementexperience, broad communication skills and demonstrated experience in financial management and understanding of business value drivers are required
- In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
- Masters degree in Engineering, preferably Chemical or Mechanical Engineering
- Demonstrated understanding of GMP regulations and compliance of biopharmaceutical manufacturing with GMP background
- Strong leadership, collaboration and influencing skills with demonstrated ability to problem solve and drive positive change
- Experienceeffectivelyleading teams in amatrixed structure as well as experience leading teams directly
- Experienceleader able to identify, hire, and develop a skilled team ofengineers and program managers
- Experience with International Standards Boards, and Global Regulatory requirements
- The ability to travel domestically and internationally as needed.
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com .
Seattle Genetics 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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* Estimated salary
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