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Remote Fmea Jobs (NOW HIRING)

Sail Biomedicines

Sr. Engineer, Drug Product

Cambridge, MA · On-site +1

$130K - $150K/yr

Provide person-in-plant or remote technical support Process Modeling & Data Analysis * Develop and ... Experience with process risk assessments, FMEA, continued process verification, process ...

Syner-G

Validation Engineer

Boston, MA · On-site +1

Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required. * Expertise in ... We define total rewards as compensation, benefits, remote work/flexibility, development ...

The Pennsylvania State University

Approval of remote and hybrid work is not guaranteed regardless of work location.For additional ... Functional Hazard Analysis, Fault Trees, Failure Modes and Effects Analyses (FMEA), Failure Modes ...

Evotecgroup

Quality Risk Manager, QTR

Seattle, WA · On-site +1

Redmond, WA with travel to Seattle, WA site, This role could be Hybrid or remote. Shifts: Days ... HACCP, HAZOP, FMEA, RRF, etc.) Why Join Us: * Growth Opportunities : We're a company that believes ...

Evotec

Quality Risk Manager, QTR

Redmond, WA · On-site +1

Redmond, WA with travel to Seattle, WA site, This role could be Hybrid or remote. Shifts: Days ... HACCP, HAZOP, FMEA, RRF, etc.) Why Join Us: * Growth Opportunities : We're a company that believes ...

Evotec

Quality Risk Manager, QTR

Seattle, WA · On-site +1

Redmond, WA with travel to Seattle, WA site, This role could be Hybrid or remote. Shifts: Days ... HACCP, HAZOP, FMEA, RRF, etc.) Why Join Us: * Growth Opportunities : We're a company that believes ...

Evotecgroup

Quality Risk Manager, QTR

Redmond, WA · On-site +1

Redmond, WA with travel to Seattle, WA site, This role could be Hybrid or remote. Shifts: Days ... HACCP, HAZOP, FMEA, RRF, etc.) Why Join Us: * Growth Opportunities : We're a company that believes ...

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Remote Fmea information

What is a remote FMEA?

A Remote FMEA (Failure Mode and Effects Analysis) is a systematic process used to identify and evaluate potential failures in a product or process, conducted by a team working remotely rather than in person. The goal is to assess the risks associated with each failure mode, prioritize them based on their impact, and develop actions to mitigate or prevent them. Remote FMEA utilizes collaboration tools such as video conferencing, shared documents, and specialized software to facilitate team discussions and documentation. This approach allows organizations to maintain quality and safety standards even when team members are not co-located.

What are the key skills and qualifications needed to thrive as a remote FMEA specialist?

To thrive as a Remote FMEA Specialist, you need a solid background in engineering or quality management, experience with risk assessment methodologies, and often a relevant technical degree. Familiarity with FMEA software tools (such as APIS IQ-RM or PTC Windchill), statistical analysis, and ISO standards is typically required. Strong analytical thinking, attention to detail, and clear communication are essential soft skills for collaborating with cross-functional teams remotely. These skills ensure accurate risk identification and mitigation, directly contributing to product reliability and safety.

What are some common challenges faced by remote FMEA specialists, and how can they be addressed?

Remote FMEA specialists often encounter challenges related to effective communication and collaboration, as FMEA typically requires cross-functional teamwork. Coordinating virtual meetings across different time zones and ensuring all voices are heard can be difficult. To address these challenges, it's helpful to use collaborative software tools, establish clear documentation protocols, and schedule regular check-ins with team members. Building strong relationships with stakeholders and maintaining open channels of communication can also help ensure a smooth FMEA process, even when working remotely.

What is the difference between Remote Fmea vs Remote Failure Mode and Effects Analysis Specialist?

AspectRemote FmeaRemote Failure Mode and Effects Analysis Specialist
CredentialsISO 13485, Six Sigma, or similar certifications often preferredSame certifications, with additional industry-specific training
Work EnvironmentRemote, primarily computer-based, collaborative toolsRemote, focused on analysis, documentation, and cross-team communication
Industry UsageManufacturing, automotive, healthcare, aerospaceManufacturing, healthcare, electronics, automotive
Job FocusPerforming FMEA tasks, risk assessment, documentationAnalyzing failure modes, developing mitigation strategies, reporting

Both roles involve risk analysis and require similar certifications, but the Remote Fmea role emphasizes performing FMEA tasks, while the Remote Failure Mode and Effects Analysis Specialist focuses on detailed analysis and strategy development. They are often used interchangeably but may differ slightly in scope and responsibilities depending on the employer.

More about Remote Fmea jobs

What cities are hiring for Remote Fmea jobs?

Cities with the most Remote Fmea job openings:

What are the most commonly searched types of Fmea jobs?

The most popular types of Fmea jobs are:

What states have the most Remote Fmea jobs?

States with the most job openings for Remote Fmea jobs include:

What job categories do people searching Remote Fmea jobs look for?

The top searched job categories for Remote Fmea jobs are:

Remote Fmea jobs near you
Infographic showing various Remote Fmea job openings in the United States as of August 2026, with employment types broken down into 97% Full Time, and 3% Contract. Highlights an 95% Physical, 3% Hybrid, and 2% Remote job distribution.

Sr. Engineer, Drug Product

Sail Biomedicines

Cambridge, MA • On-site, Remote

$130K - $150K/yr

Full-time

Re-posted 13 days ago

Job description

Position Summary

We are seeking an Engineer / Scientist to support drug product process development, process characterization, technology transfer, and manufacturing support for targeted lipid nanoparticle (tLNP) drug product processes. This role will focus on transferring complex LNP manufacturing processes to CDMOs, building and maintaining process models, supporting scale-up and process performance monitoring, and leading technical assessments for deviations, investigations, and process improvements.

The ideal candidate has hands-on experience with biologics, nanoparticle, RNA, sterile drug product, or advanced therapy manufacturing processes and is comfortable working across process development, analytical data, manufacturing execution, and quality systems.

Key Responsibilities

Process Development

  • Support process optimization and characterization activities for LNP formulation, TFF, mAb sterile filtration, and final fill.
  • Support definition and refinement of CPPs, KPPs, CMAs, IPCs, IPTs, and release-relevant process controls.
  • Collaborate with Analytical Development, Quality, Manufacturing, Supply Chain, Regulatory, and external partners to ensure process knowledge is captured and applied consistently.

Technology Transfer to CDMOs

  • Lead LNP/tLNP drug product unit operations to external manufacturing partners, including formulation, TFF/UF-DF, conjugation, sterile filtration, and final fill.
  • Role will communicate and align internal process knowledge to CDMO's through development of process descriptions and ensure alignment on CPPs, KPP, CMAs, equipment fit, single-use assembly design, and hold times. Review documentation from CDMOs surrounding batch execution at all relevant scales.
  • Review executed batch records, deviations, process data, and analytical results to confirm process performance and identify improvement opportunities.
  • Provide person-in-plant or remote technical support

Process Modeling & Data Analysis

  • Develop and maintain process models for mass balance, IPCs/IPTs, and process parameters. Use process models to support scale-up, tech transfer, batch planning, deviation impact assessments, and manufacturing readiness.
  • Support continued process verification by identifying trends, process drifts, and relationships between process inputs and product quality attributes.

Required Qualifications

  • BS with 6+ years of relevant experience or MS with 4+ years of relevant experience. Advanced degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or related field.
  • Experience in process development, manufacturing sciences, technical operations, or GMP manufacturing support.
  • Experience with biologics, RNA, LNPs, nanoparticles, sterile drug product, vaccines, cell/gene therapy, or other complex parenteral products.
  • Experience supporting CDMO manufacturing campaigns, engineering runs, GMP batches, GLP tox batches, or clinical supply manufacturing.
  • Ability to analyze process data and build mass balance or process models using Excel, JMP, Python, MATLAB, Spotfire, or similar tools.
  • Strong technical writing skills with experience authoring technical reports, deviation assessments, process descriptions, or transfer documentation.
  • Ability to work cross-functionally with internal teams and external CDMOs in a fast-paced development environment.

Preferred Qualifications

  • Experience with process risk assessments, FMEA, continued process verification, process characterization, or control strategy development.
  • Familiarity with GMP documentation, change control, CAPA, deviation systems, and regulatory expectations for biologics or sterile drug products.

Salary Range: $130,000 - $150,000

Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.

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