Site Quality Events Lead

Agilent Technologies

22d•$32 - $56

About The Position

BIOVECTRA, 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.

Requirements

Bachelor’s degree in Science or Engineering
6+ years of experience in GMP manufacturing environment

Nice To Haves

Advance degree in applicable field of study
Experience in methodology, quality, engineering, or investigations
Expertise in RCA, CAPA effectiveness, and deviation management
Strong communication, facilitation, teamwork, presentation and technical writing skills
Ability to lead cross-functional teams and manage competing priorities
Experience supporting regulatory inspections (FDA, Health Canada, EMA)
Knowledge of biologics, upstream/downstream operations, utilities, and contamination control preferred

Responsibilities

Provide daily leadership to site investigators supporting Manufacturing, QC, and Engineering
Ensure investigations meet CGMP, ICH, Health Canada, and corporate standards
Oversee and improve deviation, CAPA, and change-control lifecycle management
Establish investigation workflow, team goals, and RCA capability across the site
Represent the Windsor site during internal and external audits for deviations and CAPAs
Trend site nonconformance to identify systemic issues and improvement opportunities
Drive consistency, training, and technical coaching for investigators and SMEs
Partner cross-functionally to eliminate recurrence of contamination and process failures