d) at Thermo Fisher Scientific

Rheinfelden (Baden), Baden-Wurttemberg, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life Sciences, Clinical Supply ChainIndustries

Requirements

Bachelor's or Master's Degree in Engineering or Life Science
A minimum of 2 years working experience in pharmaceutical or related industry
Highly knowledgeable in cGMP and regulatory requirements, including 21 CFR Part 11 compliance
Know-how of qualification and mapping requirements according to cGMP regulations
A good understanding of Quality and documentation tools (Trackwise, eDMS)
Effective verbal and written communication skills in German and English
Able to work collaboratively with others to form strong positive working relationships with colleagues, clients and contractors
Ability to work on own initiative and seek assistance when required
Ability to organise and prioritise workload to ensure that timescales are met
Ability to logically fault find efficiently
High level of attention to detail and note taking
Demonstrate pride in work, through accurate timely delivery
Confident handling of quality systems such as deviations, change controls and CAPA
Strong analytical and problem-solving skills, with experience in multi-disciplinary environments

Responsibilities

Create and update existing standard operating procedure (SOPs)
Create qualification, re-assessment and Re/-mapping documents
Prepare and execute Re/-Mapping as well as the initial qualification and requalification of rooms and devices
Conduct testing, manage compliance assessments and oversee creation of deviations, investigations, and impact assessments to meet regulatory standards for three sites
Participate and represent facility department in external and internal audits, including responsibility for the execution of the audit's findings
Act as point of contact for day-to-day quality issues
Work closely with other departments and customers in resolution of all quality issues
Perform software periodic review
Monitor, track and maintain records of all facility assets, equipment and systems by using the IBM Maximo asset

Skills

Key technologies and capabilities for this role

SOP CreationQualification ProtocolsRequalificationRemappingCompliance AssessmentsDeviation ManagementInvestigationsImpact AssessmentsAuditingRegulatory ComplianceGMP

Questions & Answers

Common questions about this position

What education is required for the Compliance Engineer role?

A Bachelor's or Master's Degree in Engineering or Life Science is required.

What experience is needed for this position?

A minimum of 2 years working experience in pharmaceutical or related industry is required, along with high knowledge in cGMP and regulatory requirements including 21 CFR Part 11 compliance.

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

The role is based in an office environment with standard Monday-Friday schedule and involves on-site activities like room and device qualifications for three sites.

What key skills are needed for success in this role?

Key skills include effective verbal and written communication in German and English, ability to work collaboratively, organize and prioritize workload, logical fault finding, and high attention to detail.

What does a typical day look like for a Compliance Engineer here?

A typical day involves creating and updating SOPs, preparing qualification documents, executing mappings and qualifications of rooms and devices, conducting compliance assessments, participating in audits, and resolving quality issues with other departments.

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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