{"id":1697540,"url":"https://alion.io/job/apotex-project-leader-mst-process-validation","title":"Project Leader, MST Process Validation","company":{"id":1790883,"name":"Apotex","domain":"apotex.com","url":"https://alion.io/company/apotex-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["North York, Canada"],"countries":["CA"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":73008,"max":121680,"currency":"CAD","period":"year","gross":null,"usd_annual":85475},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Excel","optional":false},{"name":"Microsoft Project","optional":false}],"status":"live","first_seen_at":"2026-09-19T02:00:00Z","employer_posted_date":"2026-09-19","last_verified_at":"2026-10-12T07:43:44Z","board_verified":true,"closed_at":null,"days_open":23,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":23},"description":"About Apotex Inc.\nApotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.\nFor more information visit: www.apotex.com.\nJob Summary\nResponsible for the development, tracking and execution of projects within the Portfolio. The Project Leader is accountable to ensure all tasks and requirements related to projects are delivered through leading of various cross-functional teams and through timely escalation as required.\nCollaborate with Stakeholders and all functional areas across the business to achieve successful project execution. Provide status updates to the Supervisor, as required and notification of any potential project delays/risks as they arise. Works directly with other department staff both internally and externally to capture and report on their projects.\nIn addition, the Project Leader MST-Process Validation is responsible for managing and ensuring the compliance of projects related to Process Validation and for the review of proposed validation documentation and strategies which ensure the validation program remains compliant with the Health Canada, FDA, EU and other regulatory guidelines. Responsible for providing guidance and acting as a resource with knowledge pertaining to the regulatory requirements of validation for various departments such as Quality, Production, Regulatory Affairs and other subsidiary groups within MST Validation.\nJob Responsibilities\nWorks in a safe manner collaborating as a team member to achieve all outcomes.\nDemonstrate Behaviours that exhibit our organizational Values: Individual Accountability, Rigour & Discipline, Continuous Improvement\nEnsure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. \nIn the absence of Supervisor, oversees daily Process Validation (PV) activities, supporting issue resolution, and ensuring timely execution of validation deliverables. Prioritizes projects and coordinates with stakeholders to meet compliance timelines and resolve scheduling conflicts.\nCollects, analyzes, and interprets manufacturing process and quality data; performs statistical evaluations to assess process performance, identify trends and variability, and support data-driven decision-making. Generates CPV reports that verify processes remain stable, capable, and in a validated state.\nReviews and approves validation protocols, reports, change controls, technical documentation, and validation strategies to ensure compliance with regulatory requirements, the Process Validation Master Plan (PVMP), and site procedures.\nProvides validation expertise and guidance to cross-functional teams, supports investigations, deviations, corrective actions, change controls, product launches, site transfers, and process improvement initiatives.\nLeads validation-related projects, monitors progress, communicates status to management, and serves as the primary liaison for process capability and validation activities.\nSupports regulatory inspections and audits, acts as an authorized designate for protocol and report approvals, and assists with the training and development of employees and internal stakeholders.\nPerforms other relevant duties as assigned.\nJob Requirements\nEducation\nDegree, Diploma or Certification in Chemistry, Pharmaceutical Technology or related science\nDemonstrated high level of knowledge, skill, or expertise in all validation concepts, with experience using statistical tools (e.g. JMP) for evaluation of process capability and control.\nExcellent oral and written communication skills.\nDemonstrated ability to work effectively as a team member with employees at all levels of the organization.\nStrong interpersonal skills.\nStrong customer service orientation.\nExcellent problem solving and troubleshooting abilities.\nAbility to analyze and recommend process improvement.\nProven organizational, time management, and project management skills.\nIntermediate to advanced computer skills in MS Excel, Word, Access, Microsoft Project, required.\nExperience\nMinimum 5 years of pharmaceutical manufacturing experience. \nMinimum of 3 years experience in a Validation role.\nKnowledge of and experience with automation, data analytics, and visualization tools for CPV, process monitoring, and data management is preferred. Experience developing automated dashboards, reports, and workflows that drive data-driven decision-making, improve process oversight, maintain data integrity, and support quality and regulatory compliance is highly desirable. \nAt Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.\nWe offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.\nThe hiring range for this position is $73,008 - $121,680 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.\nWe are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.\nThe Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.\nApotex will use artificial intelligence to screen, select and/or assess your application for this job.\nThis job posting is for a role that is currently available and vacant at Apotex.","description_format":"text","description_chars":6373,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-02T12:33:23Z"}],"visa":[],"liveness":{"score":31,"band":"fade","label":"Fading","p_open":1,"p_active":0.693,"p_room":0.45,"age_days":23,"expected_fill_days":15,"reasons":["conf:4","velocity","win:tail"],"computed_at":"2026-10-12T06:55:09Z"},"pay":{"stated_usd_annual":85475,"is_top_pay":false},"html_url":"https://alion.io/job/apotex-project-leader-mst-process-validation","json_url":"https://alion.io/job/apotex-project-leader-mst-process-validation.json","meta":{"generated_at":"2026-10-12T12:46:27Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":19951,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1790883},"rest":"https://alion.io/mcp/rest/get_company?id=1790883"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fapotex-project-leader-mst-process-validation"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fapotex-project-leader-mst-process-validation"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fapotex-project-leader-mst-process-validation"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/apotex-project-leader-mst-process-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fapotex-project-leader-mst-process-validation"}]}