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Senior Automation Engineer
Serán BioScienceUnited Statesfull_timeVerifiedPosted 12 Dec 2024
About the role
Serán 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 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.
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 with minimal employee contributions. 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
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
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 with minimal employee contributions. 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
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