[Remote] Director, Manufacturing Engineering Sterile Drug Product at Thermo Fisher Scientific

North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Bachelors degree in Engineering or related field
10+ years experience in Engineering
Knowledge and experience with Sterile Pharmaceutical manufacturing and regulations
Outstanding leadership and management skills
Strong analytical and problem-solving skills
Ability to implement global standards
Experience in leading teams and/or initiatives is helpful
Self-directed with strong partner development skills
Ability to lead and influence in a matrix and global environment
Consistent in delivering results

Responsibilities

Technical Support Machine/ Site Infrastructure
Master Planning and Business continuity planning
Asset Life Cycle
Maintenance Excellence Program
Fit and Finish Programs
Data and information exchange
Capital project governance
New Asset Start up and Readiness
Improve use of GEPs to drive standardization
Support 3 steriles manufacturing sites in North America
Root cause analysis and problem solving on infrastructure and machine issues
Remove roadblocks and drive intensity to the operations, maintenance activities, and capital project
Working alongside the sites to guarantee capital project execution, establishment, and oversight for all major investments
Key connection to the DPD- EU team growing consistency in the sterile network
Collaborate with Quality, IT, Supply Chain, and Sustainability teams to ensure that the Capital, Engineering, and Maintenance teams adhere to policies, master planning, shutdown planning, and meet company commitments

Skills

Key technologies and capabilities for this role

Manufacturing EngineeringProblem SolvingCapital Project ExecutionRoot Cause AnalysisInfrastructure ManagementMachine Issues

Questions & Answers

Common questions about this position

What experience is required for the Director, Manufacturing Engineering Steriles role?

Candidates need 10+ years of experience in Engineering with a proven track record, along with knowledge and experience in Sterile Pharmaceutical manufacturing and regulations.

What education is required for this position?

A Bachelor's degree in Engineering or related field is required, and a Master's Degree is desirable.

Is this role remote or office-based?

The role is office-based with a standard Monday-Friday work schedule and office environmental conditions.

What are the key responsibilities of this role?

Responsibilities include providing technical support for machine and site infrastructure, master planning, asset life cycle management, maintenance excellence programs, capital project governance, and improving standardization across sterile manufacturing sites.

What skills make a strong candidate for this position?

Strong candidates will have outstanding leadership and management skills, expertise in sterile pharmaceutical manufacturing, and the ability to collaborate across teams like Quality, IT, Supply Chain, and Sustainability.

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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