AO Process Engineering Coordinator
- Bachelor degree (Chemical or Mechanical Engineering preferred)
- A minimum of 7 years experience in GMP Pharmaceutical or Biotech Industry
- At least 5 years experience as Process Design and Coordination activities
- Expertise in Good Engineering Practices guidances
- In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (f.e.: GSK, GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc).
- Strong technical, HSE and quality skills in Process Engineering, Project Engineering and Project Management
- Strong verbal and written English language skills
- Understanding of finance related to CAPEX budget
- Significantly influence, challenge and educate the leadership teams in Engineering operations
- Personal credibility, confidence and robustness to drive and influence
- Capability to manage and motivate the team; Coaching and mentoring capabilities for shopfloor training and education
- Resilience, capacity for adapting in different environment and resistance to pressure
- Coordinates AO Process Engineering activities related to Capital Projects within the AO Manufacturing Dpt of the Rosia Site complying with cGMP, Company Procedures and Safety Standards.
- Reports to Process Engineering Manager and coordinates 3 to 5 Process Engineers
- Fully aligned with Process Engineering Manager, is responsible to guarantee highest standards and continuous improvement of process equipment and systems of the site, by pushing on boundaries of technology
- In particular, the operative and responsibility area involves all the installations, equipment, systems and devices used for GMP processes.
- Coordinates the AO Process Engineering Team in the execution of all technological processes required to improve performance and reliability of the equipment and production lines: is supported by internal and external resources.
- Coordinates and directly executes the Process Engineering activities in order to implement the approved Capital Project on schedule, on budget.
- Supports the Process Engineering Manager for the preparation of the Capital Budget
- Is responsible for keeping the production department technologically aligned with all applicable engineering best practices, promoting continuous improvement
- Ensures that all technical documentation is available and up to date.
- Effectively cooperates with all the departments involved in technical activities within the assigned manufacturing areas (QA, Maintenance, Validation, HSE, MS&T, RA, etc)
- Ensures readiness for internal and external audits; is directly involved as SME
- Coordinates the preparation of technical responses to engineering observations and gaps from Regulatory/Agency Inspection, Audits, Integration/Remediation Programs
- Promotes all the initiatives to increase the level of compliance of the existing facilities.
- Is "Dirigente per la sicurezza" as defined by Italian D.Lgs 81/2008 in range of Project Management activities of the assigned projects and within his areas of responsibility.
You may apply for this position online by selecting the Apply now button.
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