Process Engineer (Tech Transfer)

ref. 01272

Process Engineer (Tech Transfer)

Asset Recruitment is recruiting a Process Engineer (Tech Transfer) for a contract role, on behalf of our client, a growing pharmaceutical manufacturer in Carlow. The successful candidate will play a key part in the development of a drug product facility.

This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction into Carlow, including Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration.

The Technical Engineering role will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable standards for Quality and EHS compliance.

RESPONSIBILITIES
Safety
• Work collaboratively to drive a safe and compliant culture in Carlow. Collaborate with multiple partners (eg. network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes. Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering Carlow at Global Technical Forums as required.
• Required to comply with Merck Global Policies, Procedures and Guidelines,
regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
• To lead and execute process engineering and validation activities to support the technical transfers
Continuous Improvement
• To manage and deliver on all technical/Validation/Quality Notifcations/Change control/Project support within the technical engineering team. Use scientific, product and process understanding as a basis for developing risk based approaches to investigations and trouble shooting.
• Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making).
• Drive collaboration between group functions and proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant.
Technical Expertise
• Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation.
• Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects.

REQUIREMENTS

General
• Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage.
• Proven track-record in delivering results in a world-class supply organisation.
• A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment.
• Innovative thinker, with excellent decision-making and problem-solving skills.
• Experience of working in a cross functional environment.
• Knowledge of and experience in applying Six Sigma and Lean methodologies.
• Positive, flexible action-oriented attitude.
Technical
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
• Experience of executing and/or managing through equipment and process validation in a sterile environment
• Good shipping/Filter/Cleaning validation knowledge required
• In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing
• Knowledge of QbD/CPV desirable
• Excellent report, standards, policy writing skills required
• Automation and MES knowledge
• Proficiency in Microsoft Office and job related computer applications required
• Lean Six Sigma Methodology experience desired
• Experience in audit preparation and execution desired
• Strong Data Analysis capability
• Have proven record of process improvement implementation
• Proven record in planning and basic project management of a team to deliver on time/schedule and cost

People
• Ability to participate in highly-effective teams.
• A great communicator, decisive decision-maker with a proven ability to deliver excellence
• Strong leadership and interpersonal skills.
• Engage with our business colleagues and learn from them as well as from our own experiences
• Vendor liaison
• Effective time management and multi-tasking skills
• Demonstrable analytical and systematic problem solving skills
• Training skills
• Effective conflict resolution skills
• Strong change management skills

Education
• Degree qualification or equivalent (Science, Engineering, Technical).
• Green Belt preferable