CQV Engineer
Full-time · Oss
About the role:
Pharming is a growing company and there are several capital projects ongoing related to our animal facilities, downstream processing facility and lab facilities where CQV support is needed. The engineer will provide CQV support for all these areas.
The CQV Engineer arranges the commissioning, qualification and validation of all process equipment, facilities and utilities on the different sites (animal facilities, DSP and lab facilities) to ensure systems, facilities and equipment meet the design and performance requirements for users. He/she coaches the local team in the ongoing equipment re-qualification process, operations and performance requirements.
Areas of responsibilities:
To develop technical specifications and write the URS for equipment, systems and facilities to ensure that the intended processes can be executed and are in compliance
To write and execute qualification protocols (IOQ /PQ), including identification and resolution of non-conformances/deviations and changes and write summary reports for IOQ / PQ testing
To perform risk assessments to provide equipment, systems and facilities qualification guidance
To actively advise facilities on issues related to equipment, systems and facilities
To ensure that contractors perform equipment, systems and facilities qualifications adequately
To implement preventative and corrective actions related to CAPAs
To shape the architecture for qualification documentation
To provide improvement opportunities
To participate in the execution of engineering projects (e.g. deviations, improvements)
To ensure that qualification activities and/or engineering projects are performed timely and within budget
To coach the local team in the ongoing equipment re-qualification process, operations and performance requirements
Required skills & qualifications in order to be successful in this role:
Problem analysis: connects different aspects of information to gain insight, questions (perceived) certainties in order to come up with solutions
Decisiveness: makes timely decisions, even if all information is not available, considering the consequences
Adaptability: comfortable to act with minimal direction in a fast-paced environment and able to adjust workload based upon changing priorities
Excellent verbal and technical writing skills both in English and Dutch (French is an advantage), separating main issues from secondary issues and sharing information in a logical order
Knowledge:
Bachelor’ or Master's degree e.g. Biochemical Engineering, Chemical, Electrical, or Mechanical Engineering, Biotechnology or Life Sciences. Engineering degree is preferred.
Knowledgeable of Current Good Manufacturing Practices (cGMPs) and regulatory guidelines (EMA, FDA, ICH)
Experience:
Minimal 10 years of relevant working experience
A minimum of 5 years of cGMP CQV experience in different areas like biotechnology, pharmaceutical production and laboratory
Experience with lean manufacturing principles (Green Belt certified is an advantage)
Experience with regulatory inspections is an advantage
Logistics Specialist
Full-time · Leiden
About the role:
The logistics specialist identifies and advices logistics solutions and best practices and monitors and analyses the supply chain network involved in the manufacturing and distribution of both current and future Pharming products. The logistics specialist oversees the performance of GDP partners by metrics-, audit- and trend analysis and supports Pharming with the selection and implementation of new solutions, processes and opportunities in order to continuously improve performance, activities, processes and logistical spend.
Areas of responsibilities:
The optimization of the logistical landscape through:
Execution of center of gravity analysis,
The development and continuously monitoring of KPI’s,
The development and maintenance of vendor relations;
The implementation of GDP carrier and 3PL, 4PL management & selection tools;
Proactive inclusion and follow up of new product introduction storage and transportation requests in the daily operations;
Active collaboration in interdepartmental projects that seek or need logistical experience;
The proposal, validation and implementation of best practices for in- and outbound processes in collaboration with Pharming’s logistical service providers;
Close collaboration with procurement, sales and other internal stakeholders in the periodic 3PL, 4PL and carrier vendor selection process
A smooth transition of inventory, clients, processes and information (flows) in case a new 3PL, 4PL partner is to be onboarded.
Required skills & qualifications in order to be successful in this role:
Analytical
Assertive
Result oriented
Persistent
Decisive
Financially aware
Accurate and Motivated attitude
Knowledge:
Master’s degree in Logistics / Supply chain management
APICS CLTD certified
Experience:
3-5 years’ experience in network optimization, logistics and export management in a global pharmaceutical, chemical or food manufacturing / distribution environment