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.
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