Sr. Automation Engineer - Data Systems

Sr. Automation Engineer - Data Systems

Vacancy expired!

This person will be a key player in the conceptual design, detailed design, specification, implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and development facilities with a primary focus on OSIsoft's PI Historian and its suite of tools. They will be a primary liaison between Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of the site Historian system for cGMP production facilities. All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory.

Responsibilities: Job Function and Description

Describe the essential daily job functions.

Operational Support:

• Provides solutions to complex reliability and operational problems.

• Owns and ensures timely closure of equipment related quality systems System Support

• Subject matter expert for OSIsoft PI Historian system

• Owns and maintains the design and specifications for PI Historian

• Develops automation related SOPs

• Serves as subject matter expert for quality systems associated with PI Historian

• Evaluates new technologies for their application within a licensed GMP manufacturing facility

• Maintains systems - system & application backups, virus protection, operating system patches, etc.

Programming:

• Specifies and documents requirements

• Implements requirements following company's engineering standard practices

• Delivers system design documentation

• Programs, configures, and integrates new equipment into an existing site Historian

• Develops, reviews, and approves engineering standard practices through collaboration with partner departments - Plant and Process Engineering, Validation, etc.

• Ensure standards are followed and there is cross-site consistency for both in-house and contractor supported changes

• Develop commissioning test plans for automation changes Large Project Support

• Provides budgetary and schedule estimates for the requirements of projects related to new and existing PI Historian systems

• Communicate project requirements to vendors to obtain proposals for hardware and software changes

• Provides project team with system requirements

• Develops project documentation

• Support process and facilities engineers in equipment commissioning

• Pre/Post approve system validation protocols

• Troubleshoot and remediate exceptions found during validation

• Assists process engineers in troubleshooting and remediation of failures

• Assist in releasing system for operation

Small Project Support:

• Owns and manages business and quality systems related to projects

• Provides and/or ensures generation of all supporting documentation (scope documents; approval slides; work orders; protocols)

• Implements changes as specified in requirements documents

• Uses project management skills to schedule, track progress, and make adjustments

Education and Experience Requirements

Include educational requirements or equivalency, required years and type(s) or experience, and

necessary licenses or certificates. Specify which are required and which are preferred. For UK,

please do not use years of experience due to UK Legislation

Essential:

• Experience: minimum 5-8 years experience supporting the administration of a Multi-Site Level PI Historian Architecture and PI projects in a cGMP environment.

• Excellent understanding of OSIsoft PI Architecture; both installation and infrastructure.

• Demonstrate a high competence understanding of OSI API OPCDA, EMDVB, PI-PI, RDBMS, EVT, UFL interfaces and has successfully implemented

• Demonstrates understanding of Windows OS, Networking & System Security Fundamentals as well as expert knowledge of how PI interfaces with SCADA, PLC, OPC,

• ContinuoBatch Historians and DCS-based control systems

• Understanding of operation principles of Asset Frameworks and Event Frames, RtReports and PI Vision and demonstrated implementation of all.

Desired:

• Understanding of AF Analytics and SIMCA Software

• Background in Automation including SCADA, PLC, OPC, ContinuoBatch Historians and DCS Based control systems (DeltaV, Rockwell, Siemens, iFix).

• Virtualized Server Infrastructure and Networking technologies

• ISA-88 (standards and terminology for batch control)

Key Skills, Abilities, and Competencies

Describe critical skill and abilities needed to successfully perform the job, which should be

representative of the knowledge, skills, and abilities required. Reasonable accommodations may be

made to enable individuals with disabilities to perform the essential functions.

• Strong understanding of Data Integrity (per FDA and EMA)

• Effective verbal and written communication skills

• Able to effectively manage the automation lifecycle of controls components

• Ability to effectively document and specify control specifications; both new from the ground up, and changes to existing systems.

• Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures

• Strong verbal and written communication skills required

• Excellent interpersonal skills required

• Adherence to domestic and international GMP regulations

• Strong organizational and teamwork skills

• Ability to multi-task in a dynamic environment with changing priorities

• Proficiency with Microsoft products; ability to learn additional software applications, as the need arises - TrackWise and Maximo experience a plus.

Complexity and Problem Solving

Describe the decisions made by the incumbents on a regular basis. Include decisions within the

Incumbent's authority to make as well as those decisions that must be referred to a higher level.

• Individual must be capable of performing assignments that have loosely defined objectives that require investigation of a large number of variables.

• Can function as a technical expert to equipment and systems regarding troubleshooting and operations.

• Ability to apply diversified knowledge of engineering principles and practices to a broad variety of assignments and related fields.

• Work with cross-functional groups in developing requirements and recommendations for highly complex automation system modifications.

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

• Complete understanding and application of principles, concepts, practices, and standards.

• Full knowledge of industry practices.

• Work is performed under general direction.

• Participates in determining objectives of assignment.

• Plan schedules and arranges own activities in accomplishing objectives.

• Work is reviewed upon completion for adequacy in meeting objectives.

Internal and External Contacts

List contacts this job advises, consults, or coordinates with on a regular basis. Describe to whom the

job is accountable. Indicate each Contact category (Internal, Vendor, Customer, or Other) and

provide examples.

• In addition to working closely with members of the Facilities, Engineering and Validation (FEV) Group and external Engineering resources, this individual will have regular contact with Manufacturing and Facility clients.

• They must be able to integrate the Validation and Quality department requirements into all aspects of the daily routine.