Hovione is an independent family-owned international group of companies. From the beginning, we have set ourselves apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
About Us
Our people are the main asset for our continued success. We have over 1950 team members from 36 different nationalities located across Asia, Europe, and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
We are In it for life, working towards innovation and excellence in everything we do: for our clients, our partners, and above all, our patients.
Job Description
The successful candidate will be responsible for:
1. Performing assembly, qualification, and automation of facilities, equipment, and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry-applicable guidelines, and internal procedures.
2. Contributing to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability, and compliance with cGMP and project specifications.
3. In the early designing phases, ensuring that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications.
4. Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are duly incorporated.
5. Executing the construction, assembly, commissioning, and qualification of complex Engineering projects.
6. Creating the installation plan and maintaining a close follow-up for Engineering Projects.
7. Planning in advance to ensure the availability of necessary resources, internal and/or external, by balancing resources between multiple ongoing projects, to meet plans, and deliver the expected quality on time.
8. Based on acquired experience, searching, defining, and implementing the most adequate technical solutions for unexpected challenges during the construction, assembly, and commissioning & qualification of facilities without compromising the design concept and the process functionality, quality, and systems.
9. Reporting and escalating promptly any relevant deviations to plans or objectives, managing risk, and uncertainty; anticipating and escalating/solving roadblocks in order to prevent deviations to the goals.
10. Reviewing on a weekly basis the progress of work including any pending items and deadlines.
11. Being fully aware of specifications, drawings, work procedures, and ensuring the contractors receive the adequate documentation and training to perform the work correctly.
12. Performing change control assessments as per defined standards and procedures in place.
13. Ensuring the change management system is applied correctly and confirming that prior to execution of any additional/extra work caused by scope changes, the proper authorization is obtained.
14. Planning that relevant inspections and tests are performed in compliance with the Project standards or legal requirements.
15. Participating, issuing, revising, and/or approving commissioning & qualification-related documentation (i.e., Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.).
16. Issuing, approving, and coordinating commissioning & qualification-related documentation (i.e., Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.) and activities.
17. When applicable, leading the external qualification contractors assuring the optimal use of their time/cost.
18. Performing preparation of the commissioning and qualification activities in coordination with the involved areas (design engineering, assembly, automation, user area, QC, and QAU) according to the defined standard and procedures in place.
19. Guaranteeing the delivering of commissioned & qualified facilities that can meet user and technical requirements.
20. Developing reliable solutions for any relevant deviations to plans or objectives and making quality and timely decisions within the Engineering tasks under her/his responsibility, based on multiple sources of data.
21. On hand-over, guaranteeing that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures, and customer expectations.
22. Promoting a list of pending items with responsibilities and deadlines (punch list) that do not infringe installation compliance with cGMP and HSE guidelines.
23. SUPPORTING THE TRAINING OF THE END USER TO ENSURE THEY MAKE BEST USE OF THE EQUIPMENT.
24. Registering the user feedback for future learnings and preventing reoccurrence through coaching other team members and putting robust systems in place.
25. Applying and developing knowledge of Engineering and participating in area processes, procedures, and projects.
26. Ensuring all assigned tasks are planned and delivered on time, safely, efficiently, reliably, and in a cost-effective manner.
27. Guaranteeing the compliance to safety and legal rules on the field, coaching all resources involved, and liaising with authorities whenever necessary.
28. Participating of Audits performed by clients and health authorities, in the scope of the Qualification and Validation area.
29. Leading functional teams or projects by coordinating and overseeing project team members and activities with involved areas.
30. CeMitoring and training less experienced members of the team.
31. Developing knowledge within the Engineering team and playing a lead role in defining area processes, procedures, and projects.
32. Issue policy documents (Engineering standards, SOPs, IOPs).
33. Carrying 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.
34. Executing professional activities in compliance with GMP, internal, and external requirements as well as promoting the implementation and maintenance of Hovione's policies, systems, and procedures (COPs, HBR, SOPs, and others).
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), of 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 the MS Office package.
* MUST HAVE THE KNOWLEDGE, EXPERIENCE, AND SKILLS TO CONDUCT THEIR TASKS IN ACCORDANCE WITH THE RULES AND PROCEDURES SET DOWN.
About Hovione
Hovione is a proud Equal Opportunity Employer.
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation, or ethnicity.