Process Engineer (PEA_06.2023)

FAMAR is a European contract manufacturing and development partner, for the pharmaceutical and health & beauty industry. Building on our 70 years’ expertise, we deliver flexible solutions, from development to production and distribution. Driven by our customer-care mindset, we offer services covering the majority of pharmaceutical forms, while providing a particularly strong expertise in Liquids, Ointments and Creams. Through the outstanding knowledge and commitment of our 1850 employees and with a network of 6 production sites, 3 R&D sites and one distribution centre, we supply a wide range of more than 1800 products in 125 international markets.

We are currently seeking to recruit for Alimos BU:

Process Engineer (PEA_ 08.2023)

DUTIES AND RESPONSIBILITIES:

• Reports to Head of Production & Packaging
• Responsible for transferring new products to FAMAR Alimos production lines. Collaborates with Project Managers, QA, QC departments and customers technical team to asses and complete the transfer process successfully
• Assessment of RFQs for new products regarding process feasibility, batch size, investment needs and routings in collaboration with the Production and Packaging Manager
• Responsible to transfer current products in alternative equipment
• Responsible for organizing and facilitating project-based endeavors, which may include identifying and resolving operational issues, enhancing productivity, reducing waste, improving customer service, or reducing costs.
• Analysis of shoopfloor’’s processes by making suggestions on how to improve them, working with other departments in recognizing opportunities, making and implementing changes, and sustaining improvements. Recognizing opportunities, making and implementing changes, and sustaining improvements
• Supervises trials, engineering and validation batches. Ensures appropriate execution of the production and sampling process together with IPC, QC, QA personnel
• Responsible to review/approve trial, validation protocols and reports issued by QA department
• Responsible to prepare, review and update Manufacturing Instructions for all products
• Responsible to prepare, review and update working instruction and templates of the Production department
• Responsible to train relevant production personnel in new or updated manufacturing instructions, standard operating procedures and working instructions
• Collaborates with the Production, QA department and customers to improve current products and production processes. Supervises manufacturing processes to identify gaps and improvement opportunities
• Participates in improvement or product remediation projects with customers, suppliers, QA, R&D departments
• Participates in risk assessment with QA department when changing a raw material supplier or specification
• Performs gap analyses and risk assessment when a new product is transferred or for changes in current products, processes or equipment
• Responsible to prepare change control for equipment or process changes in the production department
• Participates and organize training activities when a new equipment is installed in Alimos
• Responsible to implement corrective and preventive actions (CAPA) for Production department
• Responsible to investigate recurrent deviations and improve processes/equipment efficiency, yield, GMP compliance

ProfilE / SKILLS:

Academic Background:

• University Degree in Chemistry/Chemical Engineering/Pharmacy

Languages:

• Fluent in English (advanced oral and written skills).

Special Knowledge

• PC literacy (MS Office, Word, Excel, PowerPoint)
• SAP system knowledge will be an asset
• Lean 6 Sigma Certification will be an asset

Qualifications

• 3-5 years’ experience in the pharmaceutical industry in relevant position (Sterile products forms preferred)

• Ability to work under pressure and with cross-functional teams
• Problem solving
• Project management
• Change management
• Operational Excellence