Responsable de la validation - Validation Lead

Haleon•Montreal, QC

2d•Onsite

About The Position

Haleon is seeking a Validation Lead to join their Montreal (Saint-Laurent) team. This role is crucial for ensuring the reliability of processes and cleaning methods in a manufacturing site with complex regulatory factors, technical processes, and high-risk activities. The Validation Lead will be responsible for the compliance, robustness, and performance of processes and technologies, working in a stimulating environment that values excellence, rigor, and innovation.

Requirements

Proficiency in French is required for effective communication and adherence to operational and regulatory standards.
Bachelor's degree in engineering, industrial pharmacy, chemistry, or a relevant scientific or pharmaceutical discipline.
Minimum of 7 years of demonstrated experience in validation, automation, quality, and compliance within a regulated manufacturing environment (e.g., Health Canada, FDA).

Nice To Haves

Significant experience in cleaning and process validation (CPV, CCPV, technical qualification).
In-depth knowledge of regulatory standards and frameworks (GMP, FDA, ICH).
Proficiency in risk analysis tools (FMEA).
Demonstrated ability to write and review validation protocols, reports, and deliverables.
Experience with Quality Management Systems (QMS) and CAPA processes.
Familiarity with controlled environments or regulatory audits.

Responsibilities

Supervising, managing, and delivering all elements of the validation lifecycle.
Defining and maintaining the site's validation strategy, ensuring compliance with health authorities and Haleon standards.
Ensuring compliance with evolving expectations for equipment and facility qualification (C&Q), process/packaging validation, cleaning validation, continuous process validation (CPV), analytical method validation, and computer system validation.
Collaborating with engineering, quality, and technical departments to ensure validation activities are completed on time and according to Haleon standards.
Ensuring the site can demonstrate system compliance during regulatory audits (e.g., FDA, Health Canada, or ANVISA).
Maintaining the Site Validation Master Plan (SVMP).
As the site's cleaning expert, maintaining the cleaning lifecycle process by evaluating the impact of new products, processes, or changes on the site's cleaning matrix.
Training and developing the technical team to ensure cleaning validation execution demonstrates that the process reproducibly produces expected results and that adequate monitoring is in place to ensure processes remain in a validated and controlled state.
Coordinating the implementation or planning of validation tests with relevant departments and partners.