Federal Management System, Inc.
Quality Risk Management Specialist
Federal Management System, Inc., Bothell, Washington, United States, 98021
Job Summary:
This is an onsite role to help with commissioning efforts of a DeltaV system and mentor other Junior and Intermediate Engineers. The client and the project team have been working very well together with high collaboration, communication, adaptability, and a good sense of camaraderie making the work environment enjoyable and engaging. We're looking for someone who is strong technically but also a great team player, collaborative, and ready to work as "one team". There is room for continued site support post commissioning as well.
Top Must Have's:
Strong Process Automation project & commissioning experience with the DeltaV platform in a Pharma/Biotech environment.
Familiarity with ISA 88, GAMP, cGAMP.
Clear understanding of Software Development Life Cycle (SDLC), Agile methodologies, C&Q activities.
RESPONSIBILITIES:
Responsible for the design and integration of DeltaV distributed control systems for client applications and processes.
Support and take a responsible role in the Project Technical Team.
Develop familiarity with the clients manufacturing DeltaV system standards.
Implement clients DeltaV Automation Standards throughout projects.
Implement best practices from previous projects.
Create Functional Specification (FS) for the client's pharmaceutical process to describe the functional requirements for the DeltaV system.
Interpret technical Functional Specification (FS) and translate to Detailed Designs and software configuration.
Create Detailed Design Specification (DS/DDS) to be used for DeltaV software configuration.
Responsible for Software Development in DeltaV platform.
Participate in design and code reviews from functional teams.
Conduct and oversee Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning and qualification activities for DeltaV software and equipment.
Support commissioning and qualification activities at client site.
Assist in planning, organizing, monitoring, and oversight of all phases of test automation.
Collaborate with cross-functional teams to ensure appropriate requirements gathering for commissioning and qualification activities.
SKILLS:
Proactive mindset.
Natural problem solver.
Skilled in writing protocols and collaboration.
Demonstrated skill with scripting and test automation.
Mentor, guide and support fellow team members.
Drive for innovation and continuous improvement.
Effectively organize and prioritize tasks to make the most of available time.
Qualifications:
• Bachelor's or Graduate's Degree in engineering, chemical engineering, electrical engineering or computer engineering, or equivalent experience.
• Experience with SCADA, PLCs, HMI, APIs, SQL software and systems is not required but desirable.
• Over 6 years relevant DeltaV experience in pharmaceutical or biopharmaceutical industry.
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This is an onsite role to help with commissioning efforts of a DeltaV system and mentor other Junior and Intermediate Engineers. The client and the project team have been working very well together with high collaboration, communication, adaptability, and a good sense of camaraderie making the work environment enjoyable and engaging. We're looking for someone who is strong technically but also a great team player, collaborative, and ready to work as "one team". There is room for continued site support post commissioning as well.
Top Must Have's:
Strong Process Automation project & commissioning experience with the DeltaV platform in a Pharma/Biotech environment.
Familiarity with ISA 88, GAMP, cGAMP.
Clear understanding of Software Development Life Cycle (SDLC), Agile methodologies, C&Q activities.
RESPONSIBILITIES:
Responsible for the design and integration of DeltaV distributed control systems for client applications and processes.
Support and take a responsible role in the Project Technical Team.
Develop familiarity with the clients manufacturing DeltaV system standards.
Implement clients DeltaV Automation Standards throughout projects.
Implement best practices from previous projects.
Create Functional Specification (FS) for the client's pharmaceutical process to describe the functional requirements for the DeltaV system.
Interpret technical Functional Specification (FS) and translate to Detailed Designs and software configuration.
Create Detailed Design Specification (DS/DDS) to be used for DeltaV software configuration.
Responsible for Software Development in DeltaV platform.
Participate in design and code reviews from functional teams.
Conduct and oversee Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning and qualification activities for DeltaV software and equipment.
Support commissioning and qualification activities at client site.
Assist in planning, organizing, monitoring, and oversight of all phases of test automation.
Collaborate with cross-functional teams to ensure appropriate requirements gathering for commissioning and qualification activities.
SKILLS:
Proactive mindset.
Natural problem solver.
Skilled in writing protocols and collaboration.
Demonstrated skill with scripting and test automation.
Mentor, guide and support fellow team members.
Drive for innovation and continuous improvement.
Effectively organize and prioritize tasks to make the most of available time.
Qualifications:
• Bachelor's or Graduate's Degree in engineering, chemical engineering, electrical engineering or computer engineering, or equivalent experience.
• Experience with SCADA, PLCs, HMI, APIs, SQL software and systems is not required but desirable.
• Over 6 years relevant DeltaV experience in pharmaceutical or biopharmaceutical industry.
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