Senior Installation/Validation Engineer

Company: Hovione
Location: Hightstown
Posted on: May 27, 2023

Job Description:

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.
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.

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  Supports and take lead in GMP activities like CAPA, deviation and change control and other related activities
  
  
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  In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications
  
  
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  Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated
  
  
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  Execute the construction, assembly, commissioning and qualification of complex Engineering projects
  
  
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  Create the installation plan and maintain a close follow up for Engineering Projects
  
  
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  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.
  
  
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  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.
  
  
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  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
  
  
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  Review on a weekly basis the progress of work including any pending items and deadlines.
  
  
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  Be fully aware of specifications, drawings, work procedures and ensure the contractors receive the adequate documentation and training to perform the work correctly
  
  
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  Perform change control assessments as per defined standards and procedures in place
  
  
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  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.
  
  
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  Plan that relevant inspections and tests are performed in compliance with the Project standards or legal requirements
  
  
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  Participate, issue, revise and/or approve commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.)
  
  
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  Issue, approve and coordinate commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.) and activities
  
  
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  When applicable, lead the external qualification contractors assuring the optimal use of their time/cost.
  
  
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  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
  
  
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  Guarantee the delivering of commissioned & qualified facilities that can meet user and technical requirements
  
  
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  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.
  
  
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  On hand-over, guarantee that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures and customer expectations
  
  
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  Promote a list of pending items with responsibilities and deadlines (punch list) that do not infringe installation compliance with cGMP and HSE guidelines
  
  
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  Support the training of the end user to ensure they make best use of the equipment
  
  
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  Register the user feedback for future learnings and prevent reoccurrence through coaching other team members and putting robust systems in place
  
  
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  Apply and develop knowledge of Engineering and participate in area processes, procedures and projects
  
  
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  Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
  
  
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  Guarantee the compliance to safety and legal rules on the field, coaching all resources involved and liaise with authorities whenever necessary
  
  
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  Participate of Audits performed by clients and health authorities, in the scope of the Qualification and Validation area
  
  
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  Lead functional teams or projects by coordinating and overseeing project team members and activities with involved areas
  
  
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  Coach, mentor and train less experienced members of the team.
  
  
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  Develop knowledge within the Engineering team and play a lead role in defining area processes, procedures and projects.
  
  
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  Issue policy documents (Engineering standards, SOPs, IOPs)
  
  
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  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.
  
  
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  Execute professional activities in compliance with GMP , internal and external requirements as well as promote the implementation and maintenance of Hovione -s policies, systems and procedures (COPs, HBR, SOPs and others)
  
  
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  University degree, or equivalent qualification in Engineering (Mechanical, Electrical, Civil) or similar scientific field (mandatory)
  
  
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  Experience required will be minimum 3 years in pharmaceutical environments in similar activities
  
  
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  Training and experience of GMP and HSE practices (mandatory)---
  
  
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  Advanced knowledge of legislation applicable to engineering projects and quality requirements applicable to technical installations.
  
  
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  Advanced knowledge of equipment (Mechanical, E&I), of Quality, cGxPs, ICH, ISPE and ISO guidelines as well as experience on their application.
  
  
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  Ability to respond to audits
  
  
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  Knowledge of SAP system is preferable.
  
  
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  Fluency in---written and verbal---English------
  
  
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  Computer literate with good working knowledge of the MS Office package
  
  
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  Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
  
  
  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.
  ID: 2023-9515
  External Company URL: https://www.hovione.com/

Keywords: Hovione, Trenton , Senior Installation/Validation Engineer, Engineering , Hightstown, New Jersey