Technical Specialist - Engineering Systems IV - 7165

Job Description

Company: Large Pharmaceutical Company

Title: Technical Specialist - Engineering Systems IV

Contract Position: Contract position with potential for conversion to hire

Location: Bloomington, IN

JOB ID: 7165

Description:

Potential for conversion to perm Manager

MUST HAVES: PURPOSE

Serve as Subject Matter Expert (SME) and provide administrator-level knowledge of various elec-tronic engineering systems including EDMS, BIM, Procore, EIDA, ACC, etc. from a functional per-spective. The position is the liaison between other internal stake holders such as the FFEx core team, QA, IT, and external contractors where necessary to facilitate engineering systems con-trol. The strategic direction and technical expertise provided by this role will drive project suc-cess and foster a culture of innovation and continuous improvement. RELATIONSHIPS Sr Manager/Director

Essential Functions

• Provide technical expertise to the engineering team as it relates to electronic engineering sys-tems. Lead and provide guidance to evaluate, implement, and validate a robust EDMS capable of handling a variety of document types. Serve as the technical expert related to electronic engineering systems projects. Define and support the achievement of department goals according to company objectives and strategies. Propose, guide, and evaluate solutions for process/maintenance changes and continuous pro-cess improvements. Implement new technologies for the process/maintenance, planning and coordinating of changes according to applicable regulatory procedures. Identify and mitigate potential risks and challenges in projects. Facilitate problem solving, investigations, and process improvements. Collaborate with internal stakeholders to integrate Engineering Systems with other and exist-ing systems. Ensure seamless data flow and optimize system interoperability. Create governance structure including procedures for Engineering Systems. Responsible for system administration, system upgrades and enhancements, user support, and continuous improvement. Present as the technical expert for assigned processes to auditors/inspectors regarding com-plex subject matter.
• Assist in preparing and managing engineering budgets. Follow all safety and environmental requirements in the performance of duties. Other accountabilities, as assigned.
  
  

Physical Requirements

Physical Requirements Physical Requirement Details Ability to work in an open office environment with the possibility of frequent distraction Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role)

DEVELOPMENT OF PEOPLE

Development of People Not Applicable

Qualifications

• Bachelor’s degree in engineering or related field of study from an accredited university re-quired. May consider an Associate’s degree in engineering technology or related field of study from an accredited university with a minimum of ten (10) of manufacturing experience required, prefer-ably in a pharmaceutical or life sciences industry. May consider a High School Degree or equivalent with a minimum of twelve (12) years of man-ufacturing experience required, preferably in a pharmaceutical or life sciences industry. Minimum of eight (8) years of manufacturing experience required, preferably in a pharmaceu-tical or life sciences industry. Ability to read, write and understand complicated product documentation and standard oper-ating procedures with attention to high-level concepts required. Ability to drive continuous improvements via Lean tools and Six Sigma methodologies re-quired. Excellent written communication skills, investigative writing, and computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP) required. Strong technical knowledge of Engineering Systems including EDMS, BIM, CAD, COMOS, Pro-core, EIDA, Aconex, etc. required. Proficiency in web technologies, database management, and systems integration preferred. Demonstrated ability to shape and execute a strategy in a complex international environment preferred. Solid understanding of cGMP’s and 21 CFR Part 11 requirements, quality management includ-ing principles for validation of equipment, utilities, and facilities required. Recent project execution experience, successfully led large and complex global GxP invest-ments projects required. Up to date knowledge of industry trends, best practices, and regulatory requirements related to Engineering Systems required.
  
  

Job Types: Full-time, Contract

Pay: $67.00 - $70.00 per hour

Schedule:

• 8 hour shift
• Monday to Friday
  
  

Ability to Relocate:

• Bloomington, IN 47401: Relocate before starting work (Required)
  
  

Work Location: In person

Company Description

www.techdataservice.com

www.techdataservice.com