Join a Market Leader:
Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and 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.
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to::
Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications
- Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated
- Execute the construction, assembly, commissioning and qualification of complex Engineering projects
- Create the installation plan and maintain a close follow up for Engineering Project
- Plan in advance to ensure the availability of necessary resources, internal and/or external, by balancing resources between multiple ongoing projects, to meet plans and to deliver the expected quality on time and on budget.
- Based on acquired experience, search, define and implement 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.
- Report and escalate promptly any relevant deviations to plans or objectives, managing risk and uncertainty; anticipate and escalate/solve roadblocks in order to prevent deviations to the goals
- Be fully aware of specifications, drawings, work procedures and ensure the contractors receive the adequate documentation and training to perform the work correctly
- Perform change control assessments as per defined standards and procedures in place
- Ensure the change management system is applied correctly and confirm that prior to execution of any additional /extra work caused by scope changes, the proper authorization is obtained.
- Plan that relevant inspections and tests are performed in compliance with the Project standards or legal requirements
- Participate, issue, revise and/or approve commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.)
- Issue, approve and coordinate commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.) and activities.
- Perform 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
- Develop reliable solutions for any relevant deviations to plans or objectives and make quality and timely decisions within the Engineering tasks under her / his responsibility, based on multiple sources of data.
- Lead functional teams or projects by coordinating and overseeing project team members and activities with involved areas
- Develop knowledge within the Engineering team and play a lead role in defining area processes, procedures and projects.
We are looking to recruit a Candidate::
- 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.
- Fluency in written and verbal English
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.
