Senior Engineer - Consultant
Assignments in The Netherlands, Headquarters Hoofddorp – 32/38 uur
As an experienced engineer at Progress-PME you can expect to be deployed in various capacities, including, large and small engineering projects within the pharmaceutical and biotechnology industries or healthcare sector. You can be engaged in designing, organizing, preparing, planning, executing or completing stages of projects. You’ll apply basic engineering principles, concepts, theories, and techniques in support of the business objectives of the customer. You will be able to manage project activities with equipment- and installation suppliers and other contractors.
In the role as a Senior Engineer you are (co)responsible for testing and qualifying process installations, utilities and buildings. Additionally, you will supervise and organize all the testing and qualification / validation activities and you are the contact for all the departments involved, such as production, QA and QC. If needed you can also deliver services in writing a URS, engineering, logging, installing, writing, executing and reporting commissioning/qualification/validation activities including validation masterplans, establishing required procedures, solving residual points and handover to the customer.
Depending on the assignment you can also be involved in developing, conducting or supporting feasibility studies or conceptual design for processes, process installations, utilities and buildings.
- University or Higher Professional Education (HBO) degree in biotechnology, pharmaceutical, chemical of mechanical engineering or similar;
- 10-15 years of relevant work experience in the (bio)pharmaceutical industry and/or cGMP engineering environment;
- preferably 4-7 years of relevant project management as well as process installation, utility and/or facility design experience;
- knowledge of pharmaceutical production equipment and the cGMP/EU/FDA requirements including latest developments relating to commissioning and/or qualification and/or validation;
- extensive knowledge about preparing, reading, checking and improving technical specifications (URS, functional specifications (FS), detailed specifications(DS), technical drawings, P&IDs and PFDs);
- experience in setting up and reviewing qualification and validation documents such as a VMP, qualification protocols and reports;
- experience in preparing, supporting and supervising Risk Assessments and Design Reviews;
- experience in performing qualifications, as described in protocols and test plans, validation reports and summaries either independently or in a team context;
- good communication skills;
- high proficiency in Dutch and English.
- pro-active pragmatic, flexible and customer-oriented;
- accustomed to balancing timely completion and quality;
- convincing, motivating, accurate and vigorous;
- accustomed to communicating at both management and operational level;
- a healthy growing company with an informal work environment and focus on human capital;
- a varied job in challenging projects at renowned companies in the life s sciences & healthcare industry;
- opportunities for professional development, both in practice and through courses, trainings and networking events;
- short communication lines, personal commitment, team spirit;
- an interesting and learning environment;
- a healthy work-life balance;
- a competitive salary and benefits;
- a company car.