Technical Specialist - Engineering Systems - Contract - Bloomington, IN

Proclinical is seeking a Technical Specialist - Engineering Systems to act as a liaison between internal stakeholders such as the core team, QA, IT, and external contractors.

Primary Responsibilities:

This role will provide strategic direction and technical expertise to drive project success and foster a culture of innovation and continuous improvement.

Skills & Requirements:

Bachelor's degree in engineering or related field from an accredited university.Strong technical knowledge of Engineering Systems including EDMS, BIM, CAD, COMOS, Procore, EIDA, Aconex, etc.Proficiency in web technologies, database management, and systems integration.Ability to read, write, and understand complex product documentation and standard operating procedures.Ability to drive continuous improvements using Lean tools and Six Sigma methodologies.Excellent written communication skills, investigative writing, and computer skills (MS Word, Outlook, Excel, PowerPoint, Access, SAP).Solid understanding of cGMP's and 21 CFR Part 11 requirements, quality management principles for validation of equipment, utilities, and facilities.Recent project execution experience, successfully leading large and complex global GxP investment projects.Up-to-date knowledge of industry trends, best practices, and regulatory requirements related to Engineering Systems.

The Technical Specialist - Engineering Systems's responsibilities will be:

Provide technical expertise to the engineering team regarding electronic engineering systems.Lead and guide the evaluation, implementation, and validation of a robust EDMS.Serve as the technical expert for 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 process improvements.Implement new technologies for process/maintenance, planning, and coordinating changes according to 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 existing systems, ensuring seamless data flow and optimized system interoperability.Create governance structures, including procedures for Engineering Systems.Manage system administration, upgrades, enhancements, user support, and continuous improvement.Present as the technical expert for assigned processes to auditors/inspectors.Assist in preparing and managing engineering budgets.Follow all safety and environmental requirements in the performance of duties.Other accountabilities as assigned.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDEN