Sr. Engineer, Project Automation
Overview Senior Automation Engineer is a mid-level position in the Project Automation Engineering group of FDBU. The primary purpose of this position is to provide technical direction and project coordination for automation projects, including new equipment integrations, existing equipment migrations, and continuous improvement projects. External US Senior Automation Engineer is a mid-level position in the Project Automation Engineering group of FDBU. The primary purpose of this position is to provide technical direction and project coordination for automation projects, including new equipment integrations, existing equipment migrations, and continuous improvement projects. Under minimal supervision, the Senior Automation Engineer is responsible for supporting the change management, design, procurement, development, FAT/SAT, installation, qualification, and start-up of automated systems in accordance with FDBU standards and cGMP regulatory requirements. As such, this position requires knowledge of pharmaceutical process (preferably bioprocessing like fermentation and cell culture, but open to other pharmaceutical backgrounds like small-molecule solid dosage formulations and/or injectable) equipment automation with an emphasis on DeltaV. Knowledge of Rockwell PLCs and ABB DCS systems would also be beneficial in this role. The Senior Automation Engineer will work closely with CSV and QA Validation; a strong understanding of automation validation, particularly as it applies to DeltaV software is desired. This position will directly report to the Project Automation Team Leader. MAJOR ACTIVITIES AND
Responsibilities:
Direct and work with automation integrators in the design, documentation, development, installation, and qualification of DeltaV process equipment automation projects. Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements following GAMP guidelines Update, develop, review, and approve User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing equipment and control systems Develop, revise and abide by standard operating procedures and automation engineering documents. Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with automation systems and control system software in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence Interface and build collaborative partnerships with key site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives Actively manage contractor activities to ensure work quality and safe practices to facilitation of contractor training Other duties as assigned BACKGROUND REQUIREMENTS:
Qualifications:
Proficient computer skills with experience using MS Office software Excellent documentation skills. Strong technical aptitude for problem solving and data driven decision making Must have working knowledge and demonstrated capabilities working with DCS implementation, PLCs, HMIs, data historians, industrial communication networks, and system integration in a cGMP industrial setting Demonstrated capability in programming and troubleshooting complex processes which involve the use of batch programming, data acquisition, and PID control Sound working knowledge of electrical systems, instrumentation and process controls Sound working knowledge of process control and equipment automation in biotech or pharmaceutical manufacturing facility Basic understanding of bioprocessing equipment design principles and sanitary equipment design requirements to include cGMP software quality system principles and data integrity regulations Basic understanding of theories/practices utilized by other disciplines outside primary area of expertise (e.g. validation, process engineering, quality, etc.) Proficiency with Emerson DeltaV DCS systems Working knowledge of a variety of automation software applications, process control, SFC, Ladder Logic, and structured text programming languages Working knowledge of OSI Pi Data Historian Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management Ability to organize and present technical and project management overviews to engineering staff, cross functional departments, and management without assistance Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels Maintains effective relationships across functional units gaining their trust and respect Puts accomplishing the goals of the group ahead of accomplishing individual goals Openly shares knowledge/information needed to accomplish a task or solve a problem Exhibits professionalism and sets an example for others to follow Self-starter and detail oriented Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnel Education/
Experience:
Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 7
years' experience of relevant process automation or 15
years' equivalent process automation work experience with Trade School or Associate. Must include 5
years' process automation experience in the bio-pharmaceutical industry including both upstream and purification process operations, clean process utilities, and plant utilities Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 5
years' experience of relevant process automation. Must include 3
years' process automation experience in the bio-pharmaceutical industry including both upstream and purification process operations, clean process utilities, and plant utilities, but open to other pharmaceutical backgrounds like small-molecule solid dosage formulations and/or injectable
Salary Range:
$80K -- $100K
Minimum Qualification
Mechanical Engineering, Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Direct and work with automation integrators in the design, documentation, development, installation, and qualification of DeltaV process equipment automation projects. Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements following GAMP guidelines Update, develop, review, and approve User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing equipment and control systems Develop, revise and abide by standard operating procedures and automation engineering documents. Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with automation systems and control system software in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence Interface and build collaborative partnerships with key site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives Actively manage contractor activities to ensure work quality and safe practices to facilitation of contractor training Other duties as assigned BACKGROUND REQUIREMENTS:
Qualifications:
Proficient computer skills with experience using MS Office software Excellent documentation skills. Strong technical aptitude for problem solving and data driven decision making Must have working knowledge and demonstrated capabilities working with DCS implementation, PLCs, HMIs, data historians, industrial communication networks, and system integration in a cGMP industrial setting Demonstrated capability in programming and troubleshooting complex processes which involve the use of batch programming, data acquisition, and PID control Sound working knowledge of electrical systems, instrumentation and process controls Sound working knowledge of process control and equipment automation in biotech or pharmaceutical manufacturing facility Basic understanding of bioprocessing equipment design principles and sanitary equipment design requirements to include cGMP software quality system principles and data integrity regulations Basic understanding of theories/practices utilized by other disciplines outside primary area of expertise (e.g. validation, process engineering, quality, etc.) Proficiency with Emerson DeltaV DCS systems Working knowledge of a variety of automation software applications, process control, SFC, Ladder Logic, and structured text programming languages Working knowledge of OSI Pi Data Historian Excellent organizational, verbal and written communication skills with the ability to effectively communicate within cross-functional teams and to management Ability to organize and present technical and project management overviews to engineering staff, cross functional departments, and management without assistance Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels Maintains effective relationships across functional units gaining their trust and respect Puts accomplishing the goals of the group ahead of accomplishing individual goals Openly shares knowledge/information needed to accomplish a task or solve a problem Exhibits professionalism and sets an example for others to follow Self-starter and detail oriented Ability to manage commitments for self and the team while displaying an eagerness to learn and continuously improve Excellent presentation skills with the ability to clearly articulate sound reasoning and data when recommending courses of action Ability to discuss normally encountered technical issues, both verbally and written, in a manner that is understood by non-automation personnel Education/
Experience:
Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 7
years' experience of relevant process automation or 15
years' equivalent process automation work experience with Trade School or Associate. Must include 5
years' process automation experience in the bio-pharmaceutical industry including both upstream and purification process operations, clean process utilities, and plant utilities Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 5
years' experience of relevant process automation. Must include 3
years' process automation experience in the bio-pharmaceutical industry including both upstream and purification process operations, clean process utilities, and plant utilities, but open to other pharmaceutical backgrounds like small-molecule solid dosage formulations and/or injectable
Salary Range:
$80K -- $100K
Minimum Qualification
Mechanical Engineering, Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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