Job DescriptionBIOVECTRA, now a part of Agilent, is recognized as a leader in the contract development and manufacturing space of active pharmaceutical ingredients specializing in clinical-to-commercial scale production for microbial fermentation, synthetic small molecules including ADC, HPAPI, plasmid DNA, mRNA, LNP and sterile filling capabilities. With over 650 employees at both the Windsor, NS and Charlottetown, PEI sites, BIOVECTRA supports over 100 clients, including over 20 top pharma and biotech companies.BIOVECTRA joined Agilent in 2024 and is part of Agilent’s Advanced Manufacturing Partnerships Division (AMPD), which also contains Agilent’s Nucleic Acid Solutions Division. With BIOVECTRA, Agilent aims to align advanced manufacturing capabilities, expertise, and resources to foster greater innovation and operational excellence. Within AMPD, you will have the opportunity to work with cutting-edge technologies and collaborate with a team of dedicated professionals committed to revolutionizing advanced manufacturing, making a significant impact in the industry and, most importantly, improving patient care through the manufacture of better therapeutics.The Technical Investigations Lead leads the site investigation program for manufacturing, environmental, contamination, and process-related events.The role ensures timely, compliant, scientifically sound investigations and drives the effectiveness of CAPAs that impact Windsor biologics operations.Key Responsibilities:Provide daily leadership to site investigators supporting Manufacturing, QC, and EngineeringEnsure investigations meet CGMP, ICH, Health Canada, and corporate standardsOversee and improve deviation, CAPA, and change-control lifecycle managementEstablish investigation workflow, team goals, and RCA capability across the siteRepresent the Windsor site during internal and external audits for deviations and CAPAsTrend site nonconformance to identify systemic issues and improvement opportunitiesDrive consistency, training, and technical coaching for investigators and SMEsPartner cross-functionally to eliminate recurrence of contamination and process failuresQualificationsRequired:Bachelor’s degree in Science or Engineering6+ years of experience in GMP manufacturing environmentDesired:Advance degree in applicable field of studyExperience in methodology, quality, engineering, or investigationsExpertise in RCA, CAPA effectiveness, and deviation managementStrong communication, facilitation, teamwork, presentation and technical writing skillsAbility to lead cross-functional teams and manage competing prioritiesExperience supporting regulatory inspections (FDA, Health Canada, EMA)Knowledge of biologics, upstream/downstream operations, utilities, and contamination control preferredAdditional DetailsThis job has a full time weekly schedule.The full-time equivalent pay range for this position is $31.92 - $55.86/hr CAD plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Manufacturing
