Pharmaceutical Manufacturing Specialists with Engineering Background

Pharmavise Corporation; Poland; Vor Ort; PLN 180.000 - 260.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Cross-functional collaboration

Process optimization

Regulatory compliance

CAPA handling

Lean Six Sigma

Engineering software

Ausbildung

Bachelor's degree in engineering

Advanced degree preferred

Tools

Process simulation software

Data analysis tools

Regulatory compliance systems

Jobbeschreibung

Pharmaceutical Manufacturing Specialists with Engineering Background

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Job Description

This is a remote position.

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com

We are currently seeking a skilled and dedicated professional with an engineering background to join our team as a Pharmaceutical Manufacturing Specialist. Below is a detailed job description outlining the responsibilities, qualifications, and expectations for this role.

Responsibilities

• Support pharmaceutical manufacturing operations by applying engineering principles and expertise to optimize processes, equipment, and facilities.
• Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to ensure efficient and compliant manufacturing operations.
• Lead or participate in process improvement initiatives, including the identification, evaluation, and implementation of new technologies, equipment, and manufacturing practices.
• Conduct risk assessments and develop risk mitigation strategies for manufacturing processes, equipment, and facilities to ensure product quality and compliance with regulatory requirements.
• Provide technical support for troubleshooting manufacturing issues, deviations, and investigations, and implement corrective and preventive actions (CAPAs) as needed.
• Support the design, installation, qualification, and validation of manufacturing equipment and facilities, including process equipment, utilities, and cleanrooms.
• Develop and maintain manufacturing documentation, including standard operating procedures (SOPs), batch records, and equipment qualification/validation documentation.
• Stay abreast of industry trends, advancements, and regulatory requirements in pharmaceutical manufacturing and engineering, and apply best practices to drive continuous improvement.

Qualifications

• Bachelor's degree in engineering (chemical, mechanical, electrical, or related discipline) required; advanced degree preferred.
• Minimum of 5 years of experience in pharmaceutical manufacturing or related industry, with a focus on engineering support for manufacturing operations.
• Strong understanding of pharmaceutical manufacturing processes, equipment, and facilities, including solid dosage forms, liquids, and sterile products.
• Experience with process improvement methodologies, such as Lean Six Sigma, and demonstrated ability to drive efficiency and quality improvements.
• Knowledge of regulatory requirements and guidelines governing pharmaceutical manufacturing (e.g., cGMP, FDA, EMA) and experience with regulatory inspections and audits.
• Proficiency in engineering software and tools for process simulation, equipment design, and data analysis.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Ability to work independently and manage multiple projects simultaneously, with a strong focus on results and attention to detail.

This is an exciting opportunity to contribute to the success of our pharmaceutical manufacturing operations and drive continuous improvement initiatives. Competitive compensation packages are available.

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EEO Employer:

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please [e-mail] .

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise , you become part of a team that values Excellence Through Quality.Follow us in LinkedIn for more company updates and opportunities.

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.