IT Process Engineer
Proclinical is currently recruiting for an IT Process Engineer with a global medical technology and device company located in Center Valley, PA. As the Process Engineer, you will promote and reinforce adherence to the process and policies associated with the IT Governance Policy
- Work closely with IT leadership to create and maintain procedures vital in the support of the System Development Life Cycle.
- Liaise with BBraun North America and our European parent companies to ensure technical and procedural alignment between the organizations.
- Owns the Technical Change Management Process and supporting documentation from a strategic and tactical perspective.
- Analyze, design, plan, manage, and improve the IT Governance policies and procedures.
- Facilitate teams to critically review current processes for effectiveness, quality, and simplification.
- Work with business owners to identify process challenges by analyzing process data and metrics.
- Develop standardized procedures and templates for Feasibility Studies, Cost Benefit Analysis and Return on Investment calculations and execution.
- Working knowledge and experience in process definition and improvement methodologies
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
- Other duties may be assigned
Skills and Requirements:
- Bachelor's degree in computer science or related discipline from 4 year college or university; or equivalent combination of education and experience required.
- 2 to 4 years' experience in Computer System Validation and change management of computerized systems preferred.
- Experience with ITIL Best Practices preferred but not required
- Previous experience in a Quality Change Management or IT organization, supporting systems in a Medical Device or Pharmaceutical industry preferred.
- Well versed in system lifecycle processes and methodologies, with emphasis on quality assurance and testing best practices (e.g. GAMP5, 21 CFR Part 11 and IEEE).
- Experience in creating and revising Standard Operating Procedures to meet the ever-changing Information Technology Environment.
- Experience with SAP or other Enterprise systems.
- Working knowledge of MS Office applications.
- Good communication, presentation and technical writing skills.
- Ability to multi-task and deal with changing deadlines and priorities. Be proactive and identify potential computer system validation issues and prevent adverse results.
- Ability to deal effectively with internal employees and external business contacts while conveying a positive, service-oriented attitude.
- Ability to work with minimal supervision, managing own time effectively. Be available for duties on weekends and off-hours.
If you are having difficulty in applying or if you have any questions, please contact Jake Fingado at (+1) 646-481-1930 or firstname.lastname@example.org.
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.