Specialist Software Engineer
Location: NetherlandsThe Company
This client is an international pharmaceutical organization, specialized in the packaging and distribution of medicines with a powerful sense of shared purpose toward their mission: to serve patients.Role Description
You will be responsible for the software design, development and operation of multiple regulated Software Medical Devices. The team focusses on the scale up, design, development and operation of European digital services and solutions with real patient impact.Responsibilities
- Oversee cloud infrastructure as well as their vendors;- Developing the software on AWS (Amazon Web Services);
- Work with internal and external partners both locally and remotely;
- Liaising between external vendors and internal stakeholders with different departments;
- Make sure systems comply with the company's corporate regulatory, compliance, quality and business requirements with support from relevant compliance and quality assurance teams;
- Responsible for the product and process artifacts and documentation of the software development lifecycle (standard operating procedures, design history file, user requirements, design, change control etc.);
- Provide support to the System Owner through assessment, review and approval of change management documentation.
Requirements
Desired Qualifications:- Bachelor’s degree or equivalent combination of education and experience;
- Experience in working in a regulated environment, preferably life sciences with a demonstrable understanding of MDD/MDR (preferred), GMP, or another relevant regulation;
- Experience in working under pressure; must possess good time management skills;
- Experience in software development on Amazon Web Services (AWS);
- Experience in running technical project teams;
- Fluency in written and spoken English. Dutch is not a requirement;
- Preferred: experience of pharmaceutical industry;
- Preferred: knowledge of validation processes and programs.
Preferred Skills:
- Software development:
- Experience with Amazon Web Services including API gateway, Lambda, S3, IAM, and DynamoDB;
- Experience with JSON/XML programming;
- Strong communicator and service minded;
- Liaises between external vendors and various internal teams to gather requirements for customer and/or infrastructure support;
- Leads project discussions to implement services;
- Leads stakeholder discussions communicating project status and reconciling changing business requirements with service delivery;
- Acts with a customer service-mentality serving internal and external customers by driving progress (e.g. finding the right people or driving for clear decision making);
- Can present technical work to external and internal auditors, as required;
- Problem Solving;
- Can act as 1st and 3rd level support for the company's software medical devices that could include escalating issues with vendors or engaging internal teams to resolve issues;
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information;
- Anticipates and prevents potential problems;
- Handles diverse scope of issues that require evaluation of a variety of factors including current business trends;
- Independently develops solutions that are thorough, practical and consistent with functional objectives;
- Autonomy;
- Works under minimal direction;
- Manages multiple assignments and processes. Drives multiple, simultaneous, projects to completion;
- Can navigate operational and project objectives, and handle ambiguity;
- Independently determines approach to projects.
Competencies:
- Is results and detail oriented, accurate;
- Asks questions when in doubt;
- Possesses strong negotiating and influencing skills.
Other information
- Full time on site position, part time is negotiable;- Temporary project with expected end date of 30th of June 2020.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michelle Tang.
Opis stanowiska
The Company
This client is an international pharmaceutical organization, specialized in the packaging and distribution of medicines with a powerful sense of shared purpose toward their mission: to serve patients.Role Description
You will be responsible for the software design, development and operation of multiple regulated Software Medical Devices. The team focusses on the scale up, design, development and operation of European digital services and solutions with real patient impact.Responsibilities
- Oversee cloud infrastructure as well as their vendors;- Developing the software on AWS (Amazon Web Services);
- Work with internal and external partners both locally and remotely;
- Liaising between external vendors and internal stakeholders with different departments;
- Make sure systems comply with the company's corporate regulatory, compliance, quality and business requirements with support from relevant compliance and quality assurance teams;
- Responsible for the product and process artifacts and documentation of the software development lifecycle (standard operating procedures, design history file, user requirements, design, change control etc.);
- Provide support to the System Owner through assessment, review and approval of change management documentation.
Requirements
Desired Qualifications:- Bachelor’s degree or equivalent combination of education and experience;
- Experience in working in a regulated environment, preferably life sciences with a demonstrable understanding of MDD/MDR (preferred), GMP, or another relevant regulation;
- Experience in working under pressure; must possess good time management skills;
- Experience in software development on Amazon Web Services (AWS);
- Experience in running technical project teams;
- Fluency in written and spoken English. Dutch is not a requirement;
- Preferred: experience of pharmaceutical industry;
- Preferred: knowledge of validation processes and programs.
Preferred Skills:
- Software development:
- Experience with Amazon Web Services including API gateway, Lambda, S3, IAM, and DynamoDB;
- Experience with JSON/XML programming;
- Strong communicator and service minded;
- Liaises between external vendors and various internal teams to gather requirements for customer and/or infrastructure support;
- Leads project discussions to implement services;
- Leads stakeholder discussions communicating project status and reconciling changing business requirements with service delivery;
- Acts with a customer service-mentality serving internal and external customers by driving progress (e.g. finding the right people or driving for clear decision making);
- Can present technical work to external and internal auditors, as required;
- Problem Solving;
- Can act as 1st and 3rd level support for the company's software medical devices that could include escalating issues with vendors or engaging internal teams to resolve issues;
- Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information;
- Anticipates and prevents potential problems;
- Handles diverse scope of issues that require evaluation of a variety of factors including current business trends;
- Independently develops solutions that are thorough, practical and consistent with functional objectives;
- Autonomy;
- Works under minimal direction;
- Manages multiple assignments and processes. Drives multiple, simultaneous, projects to completion;
- Can navigate operational and project objectives, and handle ambiguity;
- Independently determines approach to projects.
Competencies:
- Is results and detail oriented, accurate;
- Asks questions when in doubt;
- Possesses strong negotiating and influencing skills.
Other information
- Full time on site position, part time is negotiable;- Temporary project with expected end date of 30th of June 2020.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michelle Tang.
Dodatkowe informacje
- Ostatnia aktualizacja
- Wymiar etatu
- Pełny etat
- Rodzaj umowy
- Własna działalność
- Liczba wakatów
- 1
- Min. doświadczenie
- 2 lata
- Min. wykształcenie
- Wyższe licencjackie
- Branża / kategoria
- Praca Medycyna / Służba zdrowia