Sr Validation Engineer presso Abzena

The Sr. Validation Engineer is responsible for planning, development, project management, and execution of engineering and validation lifecycle documentation including design documentation, commissioning, qualification, and the interfaces with quality system compliance requirements.The Sr. Validation Engineer is responsible for maintaining and accessing the validation documentation archive to fulfill internal/external client and/or auditor requests. In addition, the role is responsible for all tasks related to coordinating validation support for Quality Event processes related to Change Controls, Deviations, CAPAs, and Audit Observations.  The Sr. Validation Engineer is responsible for data retrieval, compilation, verification, and comparative analysis from a variety of paper and electronic system formats. This will include authoring of studies, protocols, test scripts, and data tables to facilitate collection, expert data analysis/verification, summary reporting, and conclusions regarding acceptance criteria for validation studies conducted for new facility and equipment projects and re-qualifications.

Responsibilities

Lead Commissioning, Qualification, and Validation (CQV) activities for equipment, utilities, and facilities.

Develop and execute process validation protocols for ADC manufacturing processes, including conjugation, purification, and chemistry operations.

Author and review validation master plans, protocols, and reports (IQ/OQ/PQ).

Perform risk assessments and gap analyses to identify validation needs and ensure compliance.

Collaborate with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and Regulatory Affairs.

Support cleaning validation and thermal mapping for critical equipment.

Provide technical support on Quality Event processes such as Change Controls, Deviations, and CAPAs.

Ensure data integrity and compliance with FDA, EMA, and ICH guidelines.

Participate in regulatory inspections and provide technical expertise during audits.

Qualifications

Bachelor’s degree in Engineering, or related scientific field.

Five (5) years of experience as a Validation Engineer, Equipment Specialist, Engineer, or related role in a commercial manufacturing environment.

Five (5) years of experience with: GMP and 21CFR Part 11 compliance requirements; Laboratory systems with computer-controlled functions and process validation; Mechanical equipment engineering and software functional testing; Regulatory guidance documents; Generating concise procedures, protocols, and summary reports; Applying sound validation principles; temperature mapping; and Equipment control software.

Demonstrated ability to write Protocols, Change Controls, Deviations/CAPAs, SOPs, etc. with minimal outside input.

Demonstrated ability in Project Management dynamics and techniques, ability to contribute to project management efforts with schedule logistics, projections, and resource analysis.

Ability to support internal and external audits.

Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.

Physical Requirements

Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.

Frequently lift and or move objects up to 50 pounds.

Stand/walk during entire length of shift.

Use arms, hands and fingers to handle, feel or reach.

Ability to climb, balance, stoop, kneel, crouch, or crawl.

Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus. 

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