Senior Automation Engineer

Overview

Serán Bio Science 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 a Senior Automation Engineer to manage manufacturing and process equipment, Control Systems, as well as support facility qualifications as part of production expansion efforts.

Competitive candidates will possess a strong engineering background in the pharmaceutical/biotechnology industry with specialized expertise in spray drying and solid dosage form applications and associated validation packages. Those with experience with Rockwell automation software strongly encouraged to apply.

• Serve as primary point of contact and Subject Matter Expert for Company SCADA system(s)
• Manage system life cycles by identifying, analyzing, and designing improvements and capabilities for process equipment systems
• Explore new instrumentation technologies for implementation locally and globally
• Develop and maintain engineering documentation such as PFDs, P&’s, design drawings and specifications, design review, and protocols (FAT, SAT, and IQ)
• Develop I/O and Instrument lists as required
• Assist in conceptual design of server 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 automation engineering expertise to support investigations, CAPA’s, audits, inspections, permits, and other technical requests
• Provide Instrumentation oversight as a member of the Engineering Master Specification Team
• Adhere to consistent and predictable in-person attendance
• Responsibilities may increase in scope to align with company initiatives
• Perform other related duties as assigned

• Strong working knowledge of Rockwell software and all supporting modules (Factory Talk, FT View, Asset Center, Linx, etc.)
• Strong working knowledge of PLCs, HMIs and design
• Working knowledge of Aveva PI and Smart Sights WIN 911
• Strong understanding and demonstrated ability with engineering principles and techniques
• Knowledge of FDA cGMPs
• Proficiency in ISA standards and practices for instrumentation
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
• Excellent time management skills with a proven ability to meet deadlines
• Excellent analytical and problem-solving skills
• Multitasks and adjusts priorities in a fast-paced environment, while maintaining focus and managing disruption and/or unexpected needs
• Accepts feedback from a variety of sources and constructively manages conflict
• 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

• 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
• Preference of five (5) years of relevant GMP experience within the Pharmaceutical or Biotechnology industry

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 15 pounds at times
• Ability to walk between multiple facilities
• Must be able to access equipment that requires crouching, bending, reaching overhead and climbing a ladder
• Adheres to consistent and predictable in-person attendance

Compensation correlates to skills and experience presented by selected candidate. The company career page can be viewed for more information about culture and the community of Bend, Oregon.

Applicants…