Serán is an industry-leading drug development partner that provides a comprehensive selection of development and clinical manufacturing services to pharmaceutical and biotechnology companies. At Serán, we utilize a science-first methodology and cutting-edge technologies to enable our healthcare customers to discover and develop innovative medicines that improve patient health. To help achieve this mission, Serán is seeking an Instrumentation Engineer to serve as an instrumentation SME to manage equipment and facility qualifications in support of production expansion efforts. Competitive candidates will possess a strong engineering background in the pharmaceutical/biotechnology industry with specialized expertise in sterile and non-sterile solid dosage form applications and associated validation packages.
Duties and Responsibilities
- Serve as primary contact for external instrument engineering team
- Participate in instrument design teams, project teams, and contract engineering personnel meetings
- Identify, analyze, and design improvements and capabilities for process equipment systems
- Develop and maintain engineering documentation such as PFD’s, P&ID’s, design drawings and specifications, design review, and protocols (FAT, SAT, and IQ)
- Develop I/O and Instrument lists are required
- Assist in developing the design hardware and network architecture
- Develop Hardware Specifications and Automation plans
- Drive and manage FAT, SAT, commissioning, and installation qualification
- Support debug, operational and performance qualification, and handover to operations
- Provide instrumentation engineering expertise to support investigations, CAPA’s, audits, inspections, permits, and other technical requests
- Provide Instrumentation oversite as a member of the global Engineering Master Specification Team
- Explore new Instrumentation technologies for implementation locally and globally
- Perform other related duties as assigned
Required Skill and Ability
- Strong understanding and demonstrated ability with engineering principles and techniques
- Knowledge of FDA cGMP’s
- Proficiency in ISA standards and practices for instrumentation
- Experience with Rockwell Factory Talk and Aveeva (OSI) Pi
- Excellent verbal and written communication skills
- Strong interpersonal and customer service skills
- Excellent organizational skills and attention to detail
- Excellent time management skills with a proven ability to meet deadlines
- Excellent analytical and problem-solving skills
- Strong supervisory and leadership skills
- Ability to prioritize tasks and to delegate them when appropriate
- Ability to function well in a high-paced and at times stressful environment
- Proficient with Microsoft Office Suite or related software
Education and Experience
- Bachelor’s degree in Engineering required; Electrical, Mechanical, or Chemical Engineering disciplines preferred
- Minimum of five (5) years of process instrumentation experience in an engineering role
- Minimum of five (5) years of relevant GMP experience within the Pharmaceutical or Biotechnology industry
Physical Requirements
- Prolonged periods of sitting or standing at a desk and working on a computer
- Must be able to lift up to 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.
