Process Manufacturing Owner, St.7 at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Manufacturing, Biotechnology, PharmaceuticalsIndustries

Requirements

Degree in Chemistry/CTF/Biological Sciences or similar fields, or equivalent experience
Ability to function in a fast-paced, multifaceted environment with multiple priorities simultaneously
Strong interpersonal and communication skills, both written and oral
Strong understanding of cGMP
Skilled in internal and client meetings and interviews to elicit technical details from subject matter authorities
Proficient in using a personal computer and related software applications, with Trackwise helpful
Ability to write, handle, and review GMP documentation (Deviations, CAPAs…) and understand main quality indicators
Knowledge of injectable sterile process manufacturing
Experience within manufacturing industries
Proficiency in English and Italian

Responsibilities

Address deviations collaboratively with cross-functional groups, define investigation plans, and conduct comprehensive cause investigations for deviation events
Advise or assist in defining CAPA alongside cross-functional teams
Conduct Technical Analysis both inside and outside the technical department to provide technical assistance related to deviations, including product, Environmental Monitoring deviations, manufacturing investigations resulting from OOS and site deviations
Lead a cross-functional investigation group both within and beyond the technical department
Share updates with the Quality team, Qualified person, SLT, and Global QA during critical or significant events (NSE)
Use expertise in manufacturing processes and analytical skills to pinpoint and address manufacturing problems and cultivate continuous advancement in process operations
Support technical discussions with customers related to assigned investigations
Support Manufacturing in implementing Corrective and Preventive actions (CAPA) in collaboration with Quality Specialists (QS), and proactively identify and mitigate risks
Share lessons learned during Technical Unit huddles
Apply manufacturing process understanding and investigative abilities during client and regulatory audits for assigned deviations
Support your Manager in explaining handled deviations to auditors
Contribute to achieving "zero past due" goals in Quality (CAPA, Deviations) within your scope, and support timely RFT (Right First Time) and OTIF (On-Time In Full) goals for document submission and lot release

Skills

Key technologies and capabilities for this role

Root Cause AnalysisDeviation InvestigationsCAPAManufacturing ProcessesTechnical AnalysisCross-Functional LeadershipRisk MitigationAudit SupportOOS InvestigationsEnvironmental Monitoring

Questions & Answers

Common questions about this position

What degree or qualifications are required for this role?

A degree in Chemistry/CTF/Biological Sciences or similar fields, or equivalent experience is required.

Is this a remote position or does it require office work?

This is an office-based position with a standard Monday-Friday work schedule.

What key skills are needed for the Process Manufacturing Owner role?

Candidates need the ability to function in a fast-paced, multifaceted environment with multiple priorities, strong interpersonal and communication skills both written and oral, and technical competences in manufacturing processes.

What is the work environment like at Thermo Fisher Scientific for this position?

The role involves working in a cross-functional team focused on problem-solving, continuous improvement, and collaboration across all functions and seniority levels, including the Site Leadership Team.

What makes a strong candidate for this Process Manufacturing Owner position?

Strong candidates will have a relevant degree or equivalent experience, the ability to handle multiple priorities in a fast-paced environment, and excellent communication skills to lead cross-functional investigations.

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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