Job Description

Benefits:

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We're Hiring!

We are seeking a

Validation Associate

to join our team and support key validation and quality initiatives within our biopharmaceutical manufacturing operations. In this role, you will help implement validation strategies, execute qualification activities, and ensure successful completion of project milestones. You'll play an important part in ongoing validation efforts, quality systems, and continuous process improvement related to the manufacture and testing of formulated drug products. This position also contributes to the development of innovative validation techniques, risk management assessments, and serves as a quality resource for assigned projects.

JOB RESPONSIBILITIES

Performs commissioning and qualification of new and existing production equipment and instruments, including major capital projects under the guidance of Validation Manager/VP of Quality. Participates in optimization of existing process validation procedures and technical transfer activities, including assessments of Critical Quality Attributes and identification and analysis of Critical Process Parameters. Assists in the development of a process validation program including assessments of Critical Quality Attributes and Critical Process Parameters. Drafts, reviews, executes and approves protocols and reports related to equipment, facility, and process validation. This includes deviation reporting during execution. Executes validation/qualification protocols and reports related to equipment, process validation and technical transfer of the manufacturing processes from development and research departments to production. Under the guidance of Validation Manager/VP of Quality evaluates and updates the Validation Master Plan making sure that it remains current and aligned with corporate policies and industry standards/expectations. As a member of validation team is involved in regulatory audits and responses to audit observations and corrective actions. Works together with validation group analyzing and implementing improvement opportunities for established quality systems, validation processes, and technical transfer procedures. Understands and supports current industry practices for CAPA, Change Control, Deviation, Risk Management, and Investigation processes and procedures. Collaborates with cross functional groups, including Quality, Manufacturing, Process Development, Engineering, and Regulatory Affairs. Files and maintains controlled documents. Exhibits a good working knowledge of current GMP, ICH, Health Canada and FDA guidelines and regulations related to quality systems and validation procedures that are being updated for the new industry trends and upcoming changes. Other duties as assigned.

JOB REQUIREMENTS

2 to 3 years of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities University degree in Science, Engineering, or a related field Strong knowledge of cGMP/GDP principles and international regulatory requirements



If you're looking to grow your career in a fast-paced, quality-driven environment, apply today to become part of our dedicated team.