Engineer/Specialist, equipment & system qualification.

Brief description of the position :

In order to meet the needs of our customers in the Pharmaceutical and Biopharmaceutical sectors, FOP CONSULTANTS is looking for system and equipment validation consultants to carry out various mandates. The main missions would be to manage equipment and system validation projects, write and execute IQ, OQ and PQ validation protocols, and write the standard operating procedures (SOP) as well as the validation reports.

Main responsibilities :

Without limitation, the main tasks involve:

• Write or participate in the drafting of the Validation Master Plan (VMP);
• Participate in collaboration with the validation team in the annual qualification review of equipment and systems;
• Write standard operating procedures (SOPs) related to equipment and systems;
• Write, supervise and / or execute IQ, OQ and PQ qualification protocols for production and laboratory equipment (used for different dosage forms) and systems (HVAC, Purified Water, Purified Water for Injection, Compressed Air);
• Train production technicians on IQ, OQ and PQ qualification protocols;
• Write, if applicable, the discrepancies encountered and follow up to implement the CAPA;
• Write qualification reports for equipment and systems;
• Participate to the review and update the preventive maintenance program;
• Perform audits in order to identify gaps 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 engineering (chemical engineering), Science or in any other related field;
• 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 equipment and system qualification (HVAC, Purified Water, etc.), an asset;
• Knowledge of regulations (Health Canada, FDA);
• Excellent skills in MS Office Suite.
• Good communication and writing skills in French and English;

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.