Technical Specialist - Engineering Systems

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 [email protected]

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