About the role

Aplyr's Quick Take

This role is about leading validation efforts for manufacturing processes and cleaning procedures in a sterile environment. You'll be responsible for developing and executing validation protocols, analyzing data, and ensuring compliance with regulatory standards. It's primarily an individual contributor role focused on technical expertise.

Good fit

Ideal candidates have over 8 years of experience in process or cleaning validation, especially in sterile manufacturing. Strong analytical skills and the ability to collaborate with various teams are essential.

Worth noting

The job requires strict adherence to GMP and safety protocols, including a no-makeup policy and PPE usage. The role may involve significant interaction with regulatory audits, which could be a red flag for those uncomfortable with high-stakes scrutiny.

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How will you make an impact?

The Staff Engineer, Process and Cleaning Validation supports Thermo Fisher’s mission by ensuring manufacturing processes and cleaning procedures are validated, compliant, and capable of consistently delivering high-quality products in a sterile/aseptic environment.

What will you do?

Lead process validation (PPQ) and cleaning validation activities
Develop validation strategies for new and existing products and processes
Author and execute validation protocols and reports
Perform data analysis to support validation conclusions
Support change controls, deviations, and CAPAs
Collaborate with Manufacturing, Quality, and MS&T teams
Ensure alignment with cGMP and regulatory expectations
Support internal and external audits and inspections

How will you get here?

Education:

Bachelor’s degree in Engineering, Chemistry, Life Sciences, or related field

Experience:

8+ years of experience in process and/or cleaning validation
Experience in sterile/aseptic manufacturing environments (required)
Strong knowledge of cleaning validation, including residue limits and risk-based approaches
Experience with lifecycle validation and PPQ

Knowledge, Skills, Abilities:

Strong understanding of cGMP and regulatory requirements
Data analysis and problem-solving skills
Technical writing and documentation expertise
Ability to manage multiple projects and priorities
Strong cross-functional collaboration skills

Aplyr's read

Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
Synthesized from recent postings & public sources

What's promising

•Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
•The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
•Global presence provides diverse career opportunities across multiple regions and disciplines.

What to watch

•High pressure and fast-paced environment may not suit everyone.
•Complex organizational structure can lead to communication challenges.
•Frequent acquisitions may result in uncertainty and change for employees.

Why Thermo Fisher

•Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
•The company plays a crucial role in global scientific advancements and healthcare solutions.
•Strong focus on sustainability and corporate responsibility sets it apart in the industry.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Thermo Fisher

Thermo Fisher

thermofisher.com

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Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.