Validation Specialist - Metrology

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market.

At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time.

Position Summary
Primary resource for the development, execution, review, and approval of equipment/software validations (including Computerized Laboratory Systems), System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5. Monitors equipment/software processes for adherence to established procedures/regulatory compliance. Provides guidance for equipment/software related issues and consults with QA Management to resolve complex quality issues in a timely manner.

Essential Functions and Responsibilities

• Cross functional Metrology and QA Representative for Equipment/Software Validations
• Write, execute, review, or approve Equipment and Software Validations (IQ, OQ, PQ).
• Write, execute, review, or approve Change Controls.
• Write, review, or approve Periodic Reviews.
• Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).
• Interact frequently with laboratory/manufacturing/facility staff to provide expertise on equipment/software validations. Address conditions/practices with appropriate personnel, reports findings to QA Management.
• Issues, reviews, or approves document change requests.
• Perform QA inspections including, but not limited to, Internal Audits and Supplier Audits.
• Participate in quality and process improvement initiatives, and project teams.
• Coordinates area training.
• Participate as needed to support Client and Regulatory audits.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Ability to work in a team environment and independently as required
• Contributes to the overall operations and to the achievement of departmental goals
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
• Thorough understanding of Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments

Knowledge, Skills & Ability

• Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required.
• Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
• Ability to accomplish the described duties through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access).
• Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations.
• Ability to record data accurately and legibly.
• Ability to use judgment as dictated by the complexity of the situation.
• Ability to understand and follow verbal or demonstrated instructions.
• Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
• Proficient in Oral & Written communication skills
• Need to be able to read, write and understand English

Education & Experience

• 5 or more years of relevant experience or equivalent
• Bachelors’ degree in a Science related field or equivalent experience

Physical Requirements

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE
• Ability to stand /Sit/walk for long periods of time

Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Minaris Advanced Therapies employees are eligible for a comprehensive benefits package, including medical insurance, vision insurance, dental insurance, 401(k), paid time off, tuition assistance, and more.