About Us
Hovione is an independent family-owned international group of companies. 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.
We believe that 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.
Job Description
* Key Responsibilities:
You will be responsible for 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.
* Contribute to continuous improvement of systems to improve operations by providing necessary automation technologies, capacity, reliability, and compliance with cGMP and project specifications.
* In early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications.
* Contribute to design review phase of Engineering projects to ensure that cGMP and adequate technical solutions are duly incorporated.
* Execute construction, assembly, commissioning, and qualification of complex Engineering projects.
* Create installation plan and maintain a close follow-up for Engineering Projects.
* Plan ahead to ensure availability of necessary resources, internal and/or external, by balancing resources between multiple ongoing projects, to meet plans and deliver expected quality on time and safely.
* Based on acquired experience, search, define, and implement the most adequate technical solutions for unexpected challenges during construction, assembly, and commissioning & qualification of facilities without compromising the design concept and 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 goals.
* Review progress of work, including any pending items and deadlines, on a weekly basis.
* 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 to execution of any additional/extra work caused by scope changes, proper authorization is obtained.
* Plan relevant inspections and tests are performed in compliance with Project standards or legal requirements.
* Participate in commissioning & qualification related activities and issue, revise, and approve documentation (i.e., Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.).
* 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.
* Deliver commissioned & qualified facilities meeting user and technical requirements.
* Develop reliable solutions for relevant deviations to plans or objectives and make quality and timely decisions within Engineering tasks under responsibility, based on multiple sources of data.
* Guarantee deliverables were fully commissioned and qualified upon hand-over, 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 users 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 and participate in area processes, procedures, and projects.
* Ensure 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 the 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 a 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.
* Execute professional activities in compliance with GMP, internal and external requirements, as well as promote 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 MS Office package.
* Must have knowledge, experience, and skills to conduct their tasks in accordance with the rules and procedures set down.
About Us
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.