Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
Job description
Are you a validation expert ready to contribute to critical process improvements in a regulated environment? We are looking for a Process Validation Consultant to join our team on-site in Latham, NY. This is an exciting opportunity to work in a dynamic, cross-functional setting focused on excellence, compliance, and innovation in pharmaceutical manufacturing.
As a key player in the validation lifecycle, you will lead initiatives related to IQ, OQ, PQ, and Master Validation Plan (MVP) execution, ensuring compliance with FDA, EU GMP, and ISO 13485 standards.
Key Responsibilities
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Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment, utilities, and manufacturing processes.
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Lead the creation and deployment of the Master Validation Plan (MVP) across systems and production areas.
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Collaborate with Engineering, Quality Assurance, and Manufacturing to align and coordinate validation efforts.
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Conduct risk assessments, gap analyses, and define validation scopes and priorities.
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Generate and review validation summary reports, deviation reports, and change control documentation.
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Provide expert input and documentation support during internal/external audits and inspections.
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Train and mentor internal staff on validation best practices and evolving regulatory expectations.
Required Qualifications
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Bachelor's degree in Engineering, Life Sciences, or a related technical field.
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Minimum of 5 years of experience in process validation within a regulated industry (pharmaceuticals, biotech, or medical devices).
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Strong expertise in IQ, OQ, PQ, and MVP development and execution.
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In-depth understanding of FDA regulations, EU Annex 15, 21 CFR Part 11, ICH Q8–Q10, and cGMP standards.
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Proven experience generating and reviewing technical documentation with high accuracy.
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Strong analytical, organizational, and communication skills.
Preferred Qualifications
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Experience in aseptic processing, cleanroom environments, or sterile product manufacturing.
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Familiarity with electronic validation systems (e.g., Veeva, MasterControl).
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Certification in Lean Six Sigma, ASQ CQE, or similar validation credentials.