Job Description:
Hovione is an independent family-owned international group of companies, a top market leader in Contract Development and Manufacturing.
Our people are the main asset for our continued success, with over 1950 team members from 36 different nationalities across Asia, Europe, and North America.
We strive for innovation and excellence in everything we do, for our clients, partners, and patients. That's why we're In it for life.
Key Responsibilities:
* Perform assembly, qualification, and automation of facilities, equipment, and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry guidelines, and internal procedures.
* Contribute to continuous improvement of systems by providing necessary automation technologies, capacity, reliability, and compliance with cGMP and project specifications.
* Guarantee that cGMP and HSE requirements are incorporated in design specifications during early designing phases.
* Ensure cGMP and adequate technical solutions are duly incorporated in the design review phase of Engineering projects.
* Execute construction, assembly, commissioning, and qualification of complex Engineering projects.
* Create installation plans and maintain close follow-up for Engineering Projects.
* Plan resource availability and balance resources between multiple ongoing projects to meet plans and deliver expected quality on time and efficiently.
* Search, define, and implement adequate technical solutions for unexpected challenges during construction, assembly, and commissioning & qualification without compromising design concept and process functionality, quality, and systems.
* Escalate promptly any relevant deviations to plans or objectives, manage risk and uncertainty, anticipate roadblocks, and prevent deviations to goals.
* Review progress of work including pending items and deadlines on a weekly basis.
* Be fully aware of specifications, drawings, work procedures, and ensure contractors receive adequate documentation and training to perform work correctly.
* Perform change control assessments as per defined standards and procedures in place.
* Apply change management system correctly and confirm prior authorization before execution of additional/extra work caused by scope changes.
* Plan relevant inspections and tests in compliance with Project standards or legal requirements.
* Participate, issue, revise, and/or approve commissioning & qualification related documentation.
* Issue, approve, and coordinate commissioning & qualification related documentation and activities.
* Lead external qualification contractors assuring optimal use of their time/cost when applicable.
* Prepare commissioning and qualification activities in coordination with involved areas (design engineering, assembly, automation, user area, QC, and QAU) according to defined standard and procedures in place.
* Guarantee delivering commissioned & qualified facilities meeting user and technical requirements.
* Develop reliable solutions for any relevant deviations to plans or objectives and make quality and timely decisions within Engineering tasks under responsibility.
* On hand-over, guarantee deliverables were fully commissioned and qualified, meeting user requirements, cGMP guidelines, internal procedures, and customer expectations.
* Promote list of pending items with responsibilities and deadlines (punch list) not infringing installation compliance with cGMP and HSE guidelines.
* Support training of end-user to ensure they make best use of equipment.
* Register user feedback for future learnings and prevent reoccurrence through coaching other team members and putting robust systems in place.
* Apply and develop knowledge of Engineering, participate in area processes, procedures, and projects.
* Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably, and in a cost-effective manner.
* Guarantee compliance to safety and legal rules on the field, coaching all resources involved, and liaise with authorities whenever necessary.
* Participate in Audits performed by clients and health authorities in the scope of Qualification and Validation area.
* Lead functional teams or projects by coordinating and overseeing project team members and activities with involved areas.
* Couch, mentor, and train less experienced members of the team.
* Develop knowledge within Engineering team and play lead role in defining area processes, procedures, and projects.
* Issue policy documents (Engineering standards, SOPs, IOPs).
* Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations, and codes of practice.
Requirements:
* University degree, or equivalent qualification in Engineering (Mechanical, Electrical, Civil), or similar scientific field (mandatory).
* Extensive experience in installation management or equipment qualification, preferably with a focus in chemical plants or Pharmaceutical industry.
* Training and experience of GMP and HSE practices (mandatory).
* Advanced knowledge of legislation applicable to engineering projects and quality requirements applicable to technical installations.
* Advanced knowledge of equipment (Mechanical, E&I), Quality, cGxPs, ICH, ISPE, and ISO guidelines, as well as experience on their application.
* Ability to respond to audits.
* Fluency in written and verbal English.
* Computer literate with good working knowledge of MS Office package.
* Must have Knowledge, Experience, and Skills to conduct tasks in accordance with rules and procedures set down.
Work Environment:
At Hovione, we value differences and believe in a work environment where everyone feels supported, respected, and has the opportunity to achieve their full potential, regardless of age, gender, religion, disability, sexual orientation, or ethnicity.