What are the responsibilities and job description for the Senior Automation Engineer position at Sern BioScience?

Sern BioScience is an industry-leading drug development partner that provides a comprehensive selection of development and clinical manufacturing services to pharmaceutical and biotechnology companies. At Sern, 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, Sern 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 inthe pharmaceutical / biotechnologyindustry with specialized expertise in spray drying and solid dosage form applications and associated validation packages.

Duties and Responsibilities

Serve as primary point of contact and Subject Matter Expert for Company SCADA system(s)
Manage system lifecycles by identify, analyze, and design improvements and capabilities for process equipment systems
Explore new instrumentation technologies for implementation locally and globally
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 as required
Assist in conceptional 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 oversite as a member of the Engineering Master Specification Team
Adheres to consistent and predictable in-person attendance
Responsibilities may increase in scope to align with company initiatives
Perform other related duties as assigned

Required Skills and Abilities

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 Aveeva PI and SmartSights WIN 911

Strong understanding and demonstrated ability with engineering principles and techniques

Knowledge of FDA cGMP's

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

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

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

Physical Requirements

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. Visit https : / / www.seranbio.com / careers to learn more about company culture and the community of Bend, Oregon.

Benefits Summary :

Sern 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 with minimal employee contributions. Sern 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 access to pet insurance.

The Corporate Headquarters of Sern BioScience are located at 63047 Layton Ave, Bend, OR 97701

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