Senior Manager, Validation and Aseptic Processing at Thermo Fisher Scientific

Miami, Florida, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s or Master’s in a science/engineering field; advanced degree preferred
5+ years in GMP environments with strong validation and aseptic manufacturing experience; multi-site experience preferred
Demonstrated expertise in validation lifecycle management, aseptic behavior programs, internal auditing, and CAPA leadership
Strong knowledge of applicable regulations and standards (e.g., ISO 13485, MDSAP, FDA/ICH)
Excellent communication, influence, and ability to independently lead project teams
Good understanding of statistical techniques, with Six Sigma certification a plus

Responsibilities

Establish and maintain a standardized aseptic behavior framework, including procedures, training, observations, and metrics across all sites
Perform periodic risk assessments of aseptic operations; implement mitigation strategies, and verify effectiveness
Lead gemba/behavioral observation programs and raise systemic issues; manage and report key performance metrics to leadership
Explore and train on current industry knowledge and changing expectations to maintain status as a subject matter authority
Own QA oversight for process, cleaning, equipment, utilities, computerized systems, etc
Approve validation and qualification outputs; ensure documented rationale, statistical adequacy, and data integrity
Harmonize validation standards, templates, and practices; drive cross-site consistency and change control governance
Ensure alignment with corporate QMS, GMP, GxP, and relevant regulations/standards
Partner with Operations, Engineering, MSAT, and QC on tech transfers, change controls, deviations, and investigations with validation impact
Review regulatory trends; update policies/SOPs and training to maintain compliance
Lead a matrixed cross-site team; provide mentoring, workload prioritization, and competency development in validation and aseptic practices
Present performance, risks, and improvement plans to senior leadership; secure resources and drive accountability

Skills

Aseptic Processing

Validation

GMP Compliance

Risk Assessment

Internal Audits

Contamination Control

Behavioral Observations

QA Oversight

Process Validation

Cleaning Validation

Equipment Qualification

Utilities Validation

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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