Engineer/Specialist, process validation.

Brief description of the position :

In order to meet the needs of its clients in the (Bio)Pharmaceutical sector, FOP CONSULTANTS is looking for process validation consultants motivated to carry out mandates. The main duties would be to manage process validation projects, write and execute process validation protocols and write standard operating procedures (SOPs) and process validation reports.

Main responsibilities :

Without limitation, the main tasks involve:

• Write or participate in the writing of the Master Validation Plan (PMV);
• Verify and update the process validation matrix;
• Write standard operating procedures (SOPs) related to process activities;
• Write process validation protocols (liquid form, solid form, sterile products, etc.);
• Supervise and/or execute process validation protocols, and ensure GMP;
• Train production technicians on process validation protocols;
• Write up, if necessary, the deviations encountered and follow up to implement the CAPAs;
• Write process validation reports;
• Audit in order to identify shortcomings and put in place remediation plans;
• Provide solutions to problems encountered and perform all tasks relevant to the mandate

Qualifications :

• Bachelor's or Master's degree in science (chemistry, biochemistry, biology, etc.), engineering (chemical engineering) or any other related discipline;
• 1 (one) to 10 (ten) years of experience in industry, preferably in the (bio)pharmaceutical, agri-foods, or cosmetics sectors;
• Project management skills (an asset).
• Experience in process validation (manufacturing, packaging, sterile, etc.);
• Knowledge of regulations (Health Canada, FDA);
• Excellent skills in MS Office Suite.
• Good communication and writing skills in French and English;
• Mobility (an asset).

Personal skills :

• Leadership;
• Rigor et discipline;
• (Organize), able to manage several projects;
• Analytical and critical mindset;
• Perseverance;
• Humility.

What we offer :

In order to allow the full development of our team members, FOP CONSULTANTS guarantee the support and comfort necessary for the achievement of their mandate. The main advantages offered are as follows:

• Competitive wages;
• Group insurance;
• Professional insurance;
• Remote work, according to the customer needs;
• Vacations: 3 weeks;
• Paid sick leave: 3 days;
• Monthly transportation fees;
• Career advancement opportunity;
• Continuing education.