Alliance Biotech Solutions (ABS) is a quality partner providing first in class solutions to the biotech and life sciences industry. With Engineering, Qualification, and Compliance solutions, we are more than just consultants - we’re strategic partners committed to excellence. At ABS, our greatest asset is our people. Our team members are the cornerstone of our service delivery, and we’re dedicated to fostering an environment where talent thrives, and potential is unlimited.
POSITION SUMMARY
The Automation Validation Engineer will lead and support automation CSV activities in a cGMP environment, specializing in DeltaV and related process control systems. Responsibilities include developing and executing qualification protocols (IOQ, PQ), maintaining validation documentation, and ensuring compliance with industry regulations. The role requires working independently or in teams, managing multiple projects, and interfacing directly with clients.
Candidates should have strong knowledge of DeltaV, PLCs, SCADA, BMS, and PI Historian, along with familiarity in IT infrastructure and electrical/I&C drawings. Excellent problem-solving skills, attention to detail, and adaptability in fast-paced environments are essential.
Position Responsibilities
- Must be able to work independently, in a team environment, or leading a small team while interacting with individuals at all levels in an organization, teams, and department
- Strong understanding of common Qualification documentation and practices including but not limited to Standard Operating Procedures (SOP’s), User Requirements Specifications (URS)< Risk Assesments (RA), Functional Specification (FS), Software Design Specification (SDS), Hardware Design Specification (HDS), and Data Integrity Assessment (DIA).
- Wriging and executing, Installation Operational Qualification (IOQ) and Performance Qualification (PQ) protocols and Summary Reports including through resolution of protocol deviations.
- Expected to interface with clients and establish solid working relationships
- Ability to work on multiple projects simultaneously and coordinate execution and projects
QUALIFICATIONS
- 3 to 5 Years Experience performing Automation CSV activities in an cGMP environment, along with different environments (development, production, training, etc), specifically with a strong background in DeltaV.
- Knowledge with programmable logic controllers, configuration, troubleshooting and operation.
- Knowledge and experienced in navigating within process control systems, data historian and building management systems, such as DeltaV, PI Historian, SCADA and BMS Systems.
- Familiarity with PLC, HMI, Scada, and BMS systems
- Familiarity with IT infrastructure including but not limited to, networking, storage, and archival components
- Familiarity with generation and review of electrical and I&C drawings
- Maintaining an up-to-date knowledge of validation requirements, practices, and procedures including an understanding of ICH, GxP, GAMP5, cGMP, CFRs (Part 11, 210, and 211), FDA/EU regulatory requirements and associated guidance documents
- Support departmental documentation generation and maintenance.
- Capable to use, read and understand drawings and complex operational documentation.
SKILLS AND ABILITIES
- Excellent technical problem-solving and troubleshooting skills
- High attention to detail
- Exceptional interpersonal and organizational skills.
- Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
- Willing and able to thrive in unusually fast paced and changing environments
- Ability to work independently, while supporting other team members
- Ability to change priorities in response to company demands while continuing to deliver results
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