Job Description
A Senior Project Process Engineer is required by CareerWise Recruitment for our Sligo based pharmaceutical client. This is a 12-month contracting position. This is an Exciting New Project and you will be involved in the implementation of a new Fill Finish Pharmaceutical Line!!!
Role of this position
*Project Management: Lead and manage engineering projects related to fill finish and API processes, including scope definition, budget management, scheduling, and resource allocation.
*Technical Expertise: Provide technical expertise and guidance on fill finish and API manufacturing processes, equipment selection, and facility design to ensure compliance with regulatory requirements and industry best practices.
*Collaboration: Collaborate closely with cross-functional teams including process development, quality assurance, regulatory affairs, and operations to ensure alignment and successful execution of project goals.
*Risk Management: Identify potential risks and develop mitigation strategies to ensure project success, including proactive problem-solving and contingency planning.
*Regulatory Compliance: Ensure compliance with relevant regulatory guidelines and standards such as FDA, EMA, and cGMP throughout the project lifecycle, including documentation and validation requirements.
*Continuous Improvement: Drive continuous improvement initiatives to optimize fill finish and API manufacturing processes, enhance efficiency, and reduce costs.
* Stakeholder Communication: Maintain clear and effective communication with internal stakeholders, clients, vendors, and contractors to ensure project objectives are met within established timelines and
JOB REQUIREMENTS
*Bachelor's degree in Engineering or related field..
*Minimum of 3-5 years of experience in engineering roles within the pharmaceutical industry, with a focus on fill finish and API manufacturing.
*Strong understanding of regulatory requirements and guidelines governing pharmaceutical manufacturing processes (e.g., FDA, EMA, cGMP).
*Proven track record of successfully managing engineering projects from conception to completion, with demonstrated leadership and project management skills.
*Excellent problem-solving abilities and attention to detail, with a proactive and results-oriented approach.