Apply GMP, validation, and project-management expertise to retire pharmaceutical manufacturing assets and coordinate site conversion work in Ottawa. This Decommissioning Lead role covers process remediation and execution at a Canadian pharmaceutical contract-manufacturing facility. The site is moving from oral solid dose production toward aseptic liquid filling, requiring disciplined equipment retirement and documentation. You will work with QA, Validation, Engineering, Maintenance, EHS, Facilities, operators, and contractors. Key Responsibilities:
Identify gaps against Health Canada and FDA GMP expectations Build master plans covering assets, resources, milestones, and schedules Manage asset-specific change controls and retirement records Oversee cleaning, decontamination, and product-contact verification Coordinate removal activities with new filling construction Requirements:
Degree in Chemical, Mechanical, Process Engineering, or related field Eight or more years in pharmaceutical or GMP operations Strong CQV lifecycle and equipment-retirement understanding Knowledge of ASTM E2500, ISPE, GAMP 5, and FDA requirements Eligible to work in Canada and available onsite full-time Bring structured planning, compliance judgment, and stakeholder communication to pharmaceutical asset retirement and aseptic capacity development.
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GMP Equipment Retirement Project Lead employer: Mantu
Amaris Consulting is an exceptional employer that fosters a collaborative and innovative work culture, making it an ideal place for professionals seeking to make a meaningful impact in the field of Visual Inspection technologies. With a hybrid work model that promotes flexibility while ensuring essential onsite collaboration, employees benefit from continuous growth opportunities, comprehensive training, and the chance to work alongside cross-functional teams in a dynamic environment. The company's commitment to excellence and regulatory compliance ensures that employees are part of a team that values quality and efficiency, paving the way for professional development and success.
