Job Description
A fantastic opportunity has arisen for a Assoc. Spclst, Engineering.
Responsibilities
Generation, review and approval of process documentation.
Execution of development and qualification studies across commercial and non-commercial product.
Representing Technical Operations department at cross functional meetings.
Development and qualification of new processes.
Qualification of new equipment where appropriate.
Lead & support investigations and troubleshooting of process studies as required.
Technical support for commercial manufacturing.
Technical support for new product introduction.
Ensure compliance with the QMS, industry/company specific standards and regulations.
Demonstrate effective communication and interpersonal skills.
Proactively act to consistently improve personal knowledge and capability.
Demonstrate an awareness of own capabilities and development needs.
Lead & support continuous improvement by active participation in, and contribution to, projects and problem-solving including use of production system processes and tools.
Application of technical knowledge to enable authoring of technical documents and technical decision making.
Support audit readiness, including preparation of story boards, ensuring GMP compliant documents are available, presentation to auditors as required.
Work collaboratively to drive a safe and compliant culture in on site.
Participate in driving a high performing & inclusive culture, stimulating personal growth & development.
May be required to perform other duties as assigned.
Accountable for contribution to ensure that objectives are effectively achieved, consistent with company & regulatory requirements.
Respond to Operational and business areas, ensuring compliance with cGMP and company requirements
Support continuous improvement by active participation in, and contribution to, projects and problem- solving including use of production system processes and tools.
Ensure that adequate processes and procedures are in place and followed for all relevant process activities.
Support business critical projects related to the Technical Operations department.
Provide technical support for cross functional programs & investigations
Required Skills and Qualifications
Typical Minimum Education: Bachelor’s Degree; ideally in a Science, Engineering or other Technical discipline
Proficiency in Microsoft Office and job related computer applications required
Excellent communication, presentation and interpersonal skills
Project management skills
Flexible approach
Effective time management and multi-tasking skills
Excellent attention to detail
Trouble shooting skillsGoal/results orientated
Demonstrable analytical and systematic problem solving skills
Applied Engineering
Communication
Contractor Oversight
Driving Continuous Improvement
Engineering Standards
Equipment Qualification
Estimation and Planning
GMP Compliance
GMP Validation
Internal Audit Controls
Interpersonal Communication
Investigation Procedures
Lean Manufacturing
Manufacturing Quality Control
Manufacturing Scale-Up
Manufacturing Support
New Product Introduction Process
Process Control
Process Documentation
Process Optimization
Process Scale Up
Regulatory Requirements
Teamwork
Technology Operations
Writing Technical Documents
The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
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