Healthcare Qualification / Validation engineer (M/F) Healthcare Qualification / Validation engineer (M/F)

Davidson (France); France; Hybrid; EUR 60,000 - 90,000; Full time

Job summary

Davidson is seeking a qualification-validation engineer to work on life sciences projects, installing, revamping and periodically reviewing equipment. You will develop qualification strategies, coordinate tests, and ensure production equipment and processes are qualified and validated.

Ideal candidates possess a postgraduate degree, familiarity with GMPs/BPF and regulatory bodies, and a strong writing ability.

Qualifications

• You’ll have a postgraduate degree and be conversant with the quality regulations and guidelines of the pharmaceutical industry (GMPs/BPF, France’s ANSM agency, the FDA, etc.)
• You have a desire to coordinate and interact with different internal and external trades
• You are a first-rate writer
• Curious
• Team player
• Strong appetite for technical work

Responsibilities

• Handling operational activities used to qualify various items of equipment (analytics, production, utilities, cleaning, etc.) and validating manufacturing processes in compliance with Good Manufacturing Practices and health and safety rules
• Developing a qualification strategy and implementing operational qualification/validation
• Coordinating and/or running tests, and ensuring that equipment and processes used in production are qualified and validated
• Drafting and/or approving validation protocols and reports
• Processing non-conformities from the validation exercises and coaching those involved in qualification activities

Skills

Postgraduate degree

Stakeholder coordination

Strong writing

Curious

Team player

Technical mindset

Education

Postgraduate degree in life sciences

Job description

Joining Davidson not only means joining a group of 3,000 consultants in 6 countries and 2 continents, but also joining a company that has been voted a Great Place To Work France and Europe by its employees for no less than 4 years, as well as one of the largest B Corps in France, named Best in the World in the “employees” category in 2022! (“B Corps” form a community of companies that have decided not to be the best in the world but the best FOR the world).

Because our development is based on strong principles:

• Deep respect for all our stakeholders: consultants, customers and suppliers. Because if work “can’t buy you happiness”, it can however cause unhappiness. Therefore, we are committed to listening and acting honestly.
• Equal opportunities in the processing of our applications and in the career management of our employees. We believe in a workplace where gender equality, inclusion and diversity are the norm.
• A minimal environmental impact and a maximum societal impact. That’s why, beyond the work you’ll be carrying out, you’ll also be able to contribute to projects that Davidson supports: international solidarity work (with Planète Urgence), volunteering with charities (each Davidsonian has 3 days a year to work with them), supporting students from underprivileged backgrounds (with Article 1), investing in startups developing innovative solutions, collective and individual actions to reduce our carbon footprint, etc.
• Adhocratic management based on the implementation of the principles of “horizontal company” and “tribal management”. One important detail on this last point: well-being at work is a luxury that we must be able to grant ourselves by being a “solid” company. For Davidsonians, this means combining initiative, commitment and professionalism. Because “talent without work is nothing”. And it encourages us to recruit .. who are better than us…

We encourage applications from people with disabilities, and we are committed to meeting their specific needs in the best possible way.

Mission / Profile

As a qualification-validation engineer, you’ll be involved in projects run by Davidson for its Life Sciences customers, where you’ll work on projects to install, revamp or periodically review equipment. Your responsibilities will be as varied as:

• Handling operational activities used to qualify various items of equipment (analytics, production, utilities, cleaning, etc.) and validating manufacturing processes in compliance with Good Manufacturing Practices and health and safety rules
• Developing a qualification strategy and implementing operational qualification/validation
• Coordinating and/or running tests, and ensuring that equipment and processes used in production are qualified and validated
• Drafting and/or approving validation protocols and reports
• Processing non-conformities from the validation exercises and coaching those involved in qualification activities

Skills (pre-existing or to be acquired)

• You’ll have a postgraduate degree and be conversant with the quality regulations and guidelines of the pharmaceutical industry (GMPs/BPF, France’s ANSM agency, the FDA, etc.)
• You have a desire to coordinate and interact with different internal and external trades
• You are a first-rate writer
• Curious
• Team player
• Strong appetite for technical work

Description of the segment's business

Industry trades

Davidson works in partnership with its customers on projects geared towards an advanced, connected and environmentally-friendly future.
From participating in developing innovative products and procedures to incorporating digital and connectivity into the core of solutions (manufacturing 4.0), limiting risks and fostering sustainable development, Davidson’s consultants play a central role in shifts in industrial sectors.

We’re active in the manufacturing industry, energy conversion, transport and agribusiness, and support our customers at each stage in the life cycle of a project or business: from inception through to final delivery. To achieve this, our operations combine functional responsibilities and technological support for our customers’ organisations

Our business lines:

• Research and development, studies and engineering
• Industrial organisation, operational performance and excellence
• Quality, regulatory compliance and industrial risks
• Supply chain management
• Digital & Digital Transformation

The fields we work in:

• Automotive
• Aviation
• Rail
• Space
• Infrastructures
• Special machines
• Agribusiness
• Heavy industry
• Chemicals
• Defence