Remote Pharmaceutical Manufacturing Specialist

Pharmavise Corporation; Poland; A distancia; PLN 180.000 - 260.000; Jornada completa

Descripción de la vacante

Pharmavise Corporation seeks a Pharmaceutical Manufacturing Specialist with an engineering background to support manufacturing operations. This remote role involves collaborating across manufacturing, process development, quality assurance, and regulatory affairs to optimize processes and ensure compliance.

The ideal candidate has a Bachelor's in engineering and 5+ years in pharma manufacturing, with experience in Lean Six Sigma and familiarity with cGMP, FDA, and EMA guidelines.

Formación

• Bachelors in engineering required; advanced degree preferred.
• 5+ years in pharmaceutical manufacturing or related field with engineering focus.
• Knowledge of cGMP, FDA, EMA and regulatory inspections.

Responsabilidades

• Support pharmaceutical manufacturing operations using engineering principles to optimize processes and facilities.
• Collaborate with manufacturing, QA, regulatory affairs to ensure compliant operations.
• Lead process improvement initiatives and implement new technologies and practices.
• Perform risk assessments and develop mitigation strategies for equipment and facilities to ensure quality and compliance.
• Provide technical support for deviations and investigations and implement CAPAs.
• Assist in design, installation, qualification and validation of manufacturing equipment and facilities.
• Develop and maintain SOPs, batch records, and equipment qualification/validation docs.
• Keep up-to-date with industry trends and regulatory requirements to drive continuous improvement.

Conocimientos

Cross-functional collaboration

Process optimization

Regulatory compliance

CAPA handling

Lean Six Sigma

Engineering software

Educación

Bachelor's degree in engineering

Advanced degree preferred

Herramientas

Process simulation software

Data analysis tools

Regulatory compliance systems

Descripción del empleo

Pharmavise Corporation seeks a Pharmaceutical Manufacturing Specialist with an engineering background to support manufacturing operations. This remote role involves collaborating across manufacturing, process development, quality assurance, and regulatory affairs to optimize processes and ensure compliance.

The ideal candidate has a Bachelor's in engineering and 5+ years in pharma manufacturing, with experience in Lean Six Sigma and familiarity with cGMP, FDA, and EMA guidelines.