Process Engineer II

Job description

Details:
To provide support of technical and scientific activities including implementation of Product Control Strategies, technology transfer, product investigations, change management, and continuous improvement projects.

Key Responsibilities:
- Support technical activities related to new and existing products, process optimization, process and
equipment troubleshooting and process validation.
- Participate in technical risk assessments related to new product introduction, investigations or change associated with existing products.
- Manage, analyze and identify trends in data.
- Support activities relating to change of processes, components and raw materials utilizing Change Control Procedures.
- Support investigations relating to manufacturing issues, product release performance and/or customer complaints.
- Support Technology Transfer activities for new products into the facility.
- Support Operational Excellence by identifying projects to improve yield, lower costs and improve
efficiency.
- Create documents including Batch Documentation, Validation Protocols, Evaluation Protocols/Reports, Investigation Reports and SOPs.
- Support multiple process engineering projects and process validation initiatives.
- Provide support and review of Regulatory Documents.
- Actively participate in project teams to execute project goals and assignments.
- Interact with internal and external auditors and regulatory agencies as needed during inspections.

Contact information:
You may apply for this position online by selecting the Apply now button.

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jobDetails

Desired profile

Basic qualifications:
BS in Engineering/ Pharmaceutical Science/Life Science & Minimum 2 years' applicable experience or equivalency OR 0 years of experience with MS or PhD

Preferred qualifications:
- Knowledgeable in cGMP's and regulatory requirements
- Strong written and verbal communication skills
- Working knowledge of pharmaceutical equipment and processes
- Experienced with the investigational techniques and tools for process investigations and Technical Risk Assessment.
- Knowledgeable in the principles of cleaning validation, process validation and packaging validation
- Proficient with Microsoft Project, Word and Excel
- Statistical knowledge and use of Statistica, JMP, SAS or other data analysis software