Engineer II, QA at Thermo Fisher Scientific

St Louis, Missouri, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Substantial prior experience working within a Quality, Process Engineering, or Manufacturing organization in a highly regulated industry
Able to lift 40 lbs. without assistance
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Compliance with Cleanroom requirements: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc
Ability to work in Cold Room/Freezers (-22°F/-6°C), loud noises (equipment/machinery), office, strong odors (chemical, lubricants, biological products)
Tolerance for some degree of PPE (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Understanding of contamination/cross-contamination and aseptic practices
Ability to perform daily GEMBAs of manufacturing areas and continuously assess fit and finish of the facility
Ability to perform compliance inspections within manufacturing areas
Ability to obtain buy-in and cooperation to resolve issues

Responsibilities

Spend the majority of work hours in manufacturing areas supporting active processing and working closely with Manufacturing and Process Engineering to oversee activities from a quality perspective and provide QA-related input
Collaborate with cross-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality
Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations in preparation for internal quality audits, client audits, and regulatory inspections
Observe aseptic practices and provide immediate coaching to site colleagues to prevent contamination and cross-contamination
Participate in client and regulatory audits as a SME on the Fit and Finish, Changeover, and Change Control procedures and practices
Observe critical process steps assuring adherence to guiding procedures, batch records, and established aseptic practices and be available to manufacturing and PE for support in real time
GEMBA all active areas daily as well as other areas within the core as scheduled, and provide immediate feedback to colleagues and area management to ensure compliance with cGMP’s, site procedures, and regulatory requirements
Perform QA approval of suite and equipment changeover between client processes
Perform autoclave logbook review and facilitate corrections
Perform Fit and Finish inspections per the risk assessment and guiding procedures
Perform monthly aseptic observations of critical activities performed in Biosafety Cabinets
Attend and actively participate in MFG huddles
Lead/attend and actively participate in QA OTF Tier 1 huddles
Act as Quality Management Representative for the company as needed
Take actions to develop one’s own knowledge and skills
Perform all training requirements in a timely manner
Provide training, coaching, and mentorship to new and/or less experienced team members on quality standards and effective strategies
Qualify new team members to perform tasks that require QSME training
Write and review deviations in Trackwise as required
Author, revise, and review procedures in eDMS as required
Write and implement CAPA’s as needed
Conduct/participate in investigation interviews/RAPIDs as required

Skills

Key technologies and capabilities for this role

Quality AssuranceGMPProcess EngineeringManufacturingAseptic PracticesGembaCompliance InspectionsDeviation ManagementCross-contamination ControlPPE

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

This is not a remote position; it requires spending the majority of work hours in manufacturing areas supporting active processing.

What is the work schedule for this role?

The work schedule is Second Shift (Afternoons).

What experience is required for the Quality Engineer II position?

Substantial prior experience working within a Quality, Process Engineering, or Manufacturing organization in a highly regulated industry is required.

What are the main responsibilities in this role?

Key responsibilities include observing aseptic practices, performing daily GEMBAs of manufacturing areas, conducting audits and inspections for compliance, collaborating with cross-functional teams to improve processes, and participating in client and regulatory audits.

What makes a strong candidate for this Quality Engineer II role?

A strong candidate has substantial experience in Quality, Process Engineering, or Manufacturing in a highly regulated industry, specializes in evaluating production processes, understands contamination/cross-contamination and aseptic practices, and can provide QA input during active manufacturing.

What is the salary or compensation for this position?

This information is not specified in the job description.

What environmental conditions should I expect in this role?

Expect conditions like ability to lift 40 lbs., cleanroom restrictions (no hair products, jewelry, etc.), cold rooms/freezers at -22°F/-6°C, loud noises, some PPE required, and strong odors from chemicals and biological products.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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