Project Leader - Whitby
7 hours ago
Job description
Work ScheduleFirst Shift (Days)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting
Summary:
Lead the end-to-end delivery of SampleManager LIMS and LES digital transformation initiatives within the Quality organization, including program planning, stakeholder alignment, governance, execution, and sustained adoption.
This role partners closely with laboratory stakeholders (AO/DO operations) and Corporate IT/Quality teams to deliver compliant, scalable digital lab workflows.
Primary responsibility includes implementation and enhancement of SampleManager LIMS/LES solutions, including method execution, electronic worksheets, instrument interfaces, master data configuration, and system integrations, while ensuring validated state and business continuity for laboratory operations.
Essential Functions:
Own project delivery for LIMS/LES initiatives from initiation through hypercare, including scope, schedule, resource planning, risks/issues, and budget awareness (as applicable).
Lead project governance routines:
facilitate weekly working meetings, stakeholder readouts, and escalation management; drive timely decisions and remove blockers.
Coordinate cross-functional resources (QC, QA, IT, vendors, metrology teams) to deliver milestones and manage dependencies.
Drive organizational change management (OCM): stakeholder alignment, communications, training coordination, adoption tracking, and sustained use of new workflows.
Serve as site SME and technical lead for SampleManager LIMS and LES.
Translate laboratory operational requirements into functional and technical designs and implement solutions in SampleManager.
Configure and develop LES components such as electronic lab execution (step-based workflows, calculations, checks, prompts), method execution templates, spec/limit checks, auto-evaluations, and result validation rules.
Perform SampleManager development/configuration using relevant tools and platform capabilities.Troubleshoot complex defects involving workflow logic, calculations, permissions, instruments, interfaces, and data integrity.
Conduct impact assessments for changes/enhancements and implement controlled updates through change management.
Design, implement, and support integrations between SampleManager and Chromatography Data Systems (e.g., Empower), ERP/MES (e.g., SAP), and eDMS for controlled documents and records.
Support interface monitoring, error handling, reconciliation, and data exception management.Ensure solutions meet GMP, ALCOA+, data integrity, and 21 CFR Part 11 requirements.
Support audits/inspections by providing evidence, system explanations, and traceability.
Provide day-to-day support for QC labs (AO/DO), including incident triage, root cause analysis, and CAPA support.
Identify opportunities to improve lab efficiency using digital execution and automation (reduced manual entry, error-proofing, standardized workflows).
Required Qualifications
Education:
Bachelor's degree in Science, Engineering or Business an asset.
Experience:
4 years in a GMP / regulated environment supporting laboratory digital systems.
2 years hands-on experience with SampleManager LIMS (configuration, support, enhancements); LES experience strongly preferred.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Well organized with strong attention to detail. Ability to prioritize multiple project deliverables in a fast-paced work environment. Ability to meet deadlines and prioritize. Excellent written and oral communication skills. Ability to handle conflict effectively. Strong customer focus and commitment to results. Familiarity with Good Manufacturing Practices and lab operations. Ability to work both in a team environment as well as independently. Demonstrated computer proficiency with Microsoft Office programs and database management skills. Proficiency with English language.
Standards and Expectations:
Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives.
Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).
Maintain workspace in a clean and orderly fashion.Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).
Be client and patient conscious at all times.Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving.
Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working.
Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.Physical Requirements:
Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area.
There may be regular exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights.
Use of Personal Protective equipment may be required and may include any of the following:safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
CompensationThe salary range estimated for this position based in Canada is $69,400.00–$104,050.00.
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