Serán BioScience specializes in bringing the most challenging drug therapies to market through a comprehensive set of drug-development services and GMP manufacturing. We seek a Lead Facilities Engineer to be part of a cross functional management team to develop and oversee the engineering programs for facilities, utilities, and automation/controls needed to support the continued operation of Serán facilities. This position will be responsible for establishing engineering standards which will guide the growth initiative projects already underway, as well as future projects.
Qualified candidates will possess a thorough understanding of the processes and systems associated with the facilities, along with applicable regulations, guidelines, policies, procedures, and requirements. Effective communication is essential for extracting required information, alignment of strategies and approaches, and correcting deficiencies while maintaining good working relationships. Preference will be given to those with experience in GMP manufacturing within the pharmaceutical industry.
Supervisory Responsibilities
- Manage the Facilities Engineers responsible for the execution of engineering projects and support of the operation of the facilities, utilities, and automation/controls
- Support the department head in recruiting, hiring, training, mentoring, coaching, and team building
- Lead cross functional internal and external teams during the execution of facilities projects and development of internal programs/processes
Duties and Responsibilities
- Develops engineering programs for facilities, utilities, and automation/controls needed to support projects assigned as facility improvements and repairs
- Manages engineering programs for facilities, utilities, and automation/controls in conformance with all applicable guidelines, policies, procedures, and regulatory requirements
- Supports facility operations with a systematic approach to troubleshooting, engaging industry experts, and successful execution to deliver solutions in an effective and timely manner
- Guides the programmatic design of facilities based on the intended use
- Provides input in the development of strategy, procedures, and policy development within the organization
- Demonstrates capability of developing and recommending strategies for change while effectively communicating the rationale for the changes
- Ability to negotiate and influence internal and external customers
- Proactively identifies, communicates, and monitors regulatory changes that could have an impact on quality or compliance within the organization
- Manages department and/or project budget
- Performs other related duties as assigned
Required Knowledge, Skills and Competencies
- Knowledge of cGMPs and Global Regulatory (e.g., FDA / MHRA / EMEA) guidelines and regulations acquired through education, experience, and training
- Thorough experience with facility systems regarding design, construction, and repairs; systems include, but not limited to, HVAC, compressed gases, water systems (i.e. purified water, steam), electrical, and automation/controls plus monitoring
- Experience in facility design regarding process flow, controlled zones, fit and finish, and structural components with respect to pharmaceutical facilities
- Experience interacting with regulators and clients during audits
- Effective written, oral, and interpersonal communication skills
- Excellent leadership skills with ability to motivate and coach employees
- Strong time-management skills and the ability to organize and coordinate multiple projects at once
- Proficiency in enterprise systems, Microsoft Office Suite and other office productivity tools, with aptitude to learn new software and systems
Education and Experience
- Bachelor’s degree in an engineering discipline or another discipline with equivalent experience and training
- Minimum of 10 years of overall experience in the pharmaceutical / biopharmaceutical industry preferred
- Minimum of 10 years of engineering experience with facilities and utilities preferred
- Minimum of 5 years of engineering experience with automation and controls required
Physical Requirements
- Physically able to work throughout Serán facilities and campus
- Prolonged periods of time standing, kneeling, crawling, or climbing ladders
- Required to work in settings with extreme cold or heat at various times of year
- Must be able to lift 15 pounds at times
Compensation correlates to skills and experience presented by selected candidate. Visit
https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs. Serán fully funds employees and their household with dental, vision and one medical plan option. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with pet programs as well.