process engineer

Purpose of the Mission:

Provide expertise in the implementation of good engineering & design practices and solutions to support design, execution and commisionning / qualification phases of CapEx Projects.

Act as the Process Engineering in the company’s Vaccines Secondary Equipment projects in Belgium by delivering equipment mainly in the following technologies:

• Isolator technologies (Formulation and Filling)

• Aseptic Filling lines (Vials, Syringes)

• Freeze Dryer

• Gloves Tester

• Room Decontamination (Dryfog)

Primary Tasks & Responsibilities:

In coordination with Engineering Office and Project Management, ensure correct design, construction, commissioning and qualification in full compliance with internal requirements and authorities’ requirement of Secondary equipments and Aseptic technologies package.

Related to these packages, it includes :

• Being the company’s representative for all Secondary equipments and Aseptic technologies-related activities and installations

• Supporting the E.O in management of activities related to this package

• Ensure regular technical contact with MPU representatives (User, QA, Validation, Maintenance,…)

• Ensuring alignment between E.O and the company’s Specification and Guidance

• Reviewing design and technical documentation

• Following-up construction & all testing activities falling under the package’ scope

• Ensure systems start-up and punchlist solving

• Writing and executing commissioning and qualification protocols/reports

• Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities

• Facilitating handover process towards the end user

Experience, Knowledge & Soft Skill Requirements:

In the expertise domain of pharmaceuticals Secondary equipments and Aseptic technologies systems, needed capabilities embrace: Secondary equipments - Isolator technologies.

Hard Skills:

Demonstrates deep knowledge and expertise in design, implementation and qualification of engineering projects.
Key capabilities include:

• Definition of functional, technical and quality requirements

• Realisation of reviews of process studies, P&ID’s and layouts

• Oversight contractor’s performance

• Integration of operability and EHS requirements at all design steps

• Preparation of the project testing, commisioning and inspection requirements

• Organize legal conformity visits

• On-site verification of execution according to good practices

• Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…), …

Soft Skills:

• Team working & Communication / Autonomy / Contractors’ management

• Good project integration experience: organisation, schedule, qualification, validation, technologies

• Experience in the Pharmaceutical industry

• Perform his/her work in an EHS and cGMP high-demanding environnement

Education, Methodology & Certification Requirements:

• Engineering degree with 7 years experience as Process Engineer in Secondary Equipments and Aseptic Technologies domains

• Strong Experience in the Pharmaceutical industry and cGMP environment

• BA4 BT electrical certification granted by Employer

ICT Skills (software, operating systems, hardware, etc.):

MS Office (Word, Excel, Power point)

Language Proficiency Requirements:

French/English

Consultancy

We offer an attractive salary with extra-legal advantages:

• Group insurance

• Hospitalisation insurance

• Meal vouchers of 7 euros gross per working day

• Reimbursement km or company car

• Monthly allowance (80 euros net per month)

• A 13th month

• Training

• Etc.

A rate as a freelancer is also possible.