Job Description:
A Senior Project Process Engineer is required by CareerWise Recruitment for our Sligo-based pharmaceutical client. This 12-month contracting position involves implementing a new Fill Finish Pharmaceutical Line, an exciting project that will utilize your expertise and skills.
Role of this Position
* Project Management: Lead engineering projects related to fill finish and API processes, including scope definition, budget management, scheduling, and resource allocation.
* Technical Expertise: Provide technical guidance on fill finish and API manufacturing processes, equipment selection, and facility design to ensure compliance with regulatory requirements and industry best practices.
* Cross-Functional Collaboration: Work closely with process development, quality assurance, regulatory affairs, and operations teams 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 initiatives to optimize fill finish and API manufacturing processes, enhance efficiency, and reduce costs.
* Stakeholder Communication: Maintain clear communication with internal stakeholders, clients, vendors, and contractors to ensure project objectives are met within established timelines.
Job Requirements
* Bachelor's degree in Engineering or a 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).
* Demonstrated leadership and project management skills, with a proven track record of successfully managing engineering projects from conception to completion.
* Excellent problem-solving abilities and attention to detail, with a proactive and results-oriented approach.