Senior Automation Engineer at Serán BioScience

Bend, Oregon, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

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
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
Strong engineering background in the pharmaceutical/biotechnology industry with specialized expertise in spray drying and solid dosage form applications and associated validation packages
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

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
Responsibilities may increase in scope to align with company initiatives
Perform other related duties as assigned
Manage manufacturing and process equipment, Control Systems, as well as support facility qualifications as part of production expansion efforts

Skills

SCADA

Rockwell automation software

P&ID

PFD

FAT

SAT

spray drying

solid dosage form

validation

CAPA

PLC

HMI

instrumentation

Serán BioScience

Contract development and manufacturing for pharmaceuticals

About Serán BioScience

Serán BioScience specializes in providing drug development and manufacturing services as a Contract Development and Manufacturing Organization (CDMO). They offer a variety of services, including preformulation, formulation development, dosage form development, spray drying, and particle engineering. Their operations adhere to current Good Manufacturing Practice (cGMP) standards, ensuring high quality and safety in their products through rigorous analytical quality control. Serán BioScience serves a wide range of clients, from small biotech startups to large pharmaceutical companies, and is distinguished by its flexibility in tailoring services to meet specific client needs. The company's goal is to enhance the efficiency and effectiveness of drug development processes for their clients.

Bend, OregonHeadquarters

2016Year Founded

$194.5MTotal Funding

GROWTH_EQUITY_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Paid Vacation

401(k) Retirement Plan

Health Insurance

Life Insurance

Disability Insurance

Mental Health Support

Pet Insurance

Risks

Emerging CDMOs in Asia offer lower-cost services, impacting Serán's market share.

Potential delays in new facility construction could affect expansion plans.

Global talent shortage may hinder recruitment for Serán's expansion.

Differentiation

Serán specializes in advanced drug formulation techniques, including spray drying and particle engineering.

The company offers cGMP manufacturing and analytical quality control services.

Serán's flexibility allows tailored services to meet specific client needs.

Upsides

Serán announced a $200 million strategic growth transaction for expansion.

The company plans to build a new commercial-scale manufacturing facility.

Increased demand for personalized medicine aligns with Serán's formulation expertise.

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