Cache of job #14144203

Job Title

Validation Lead (Associate Director, Engineering)

Employer

MSD

Location

Carlow

Description

A fantastic opportunity has arisen for a Validation Lead (Associate Director, Engineering) . This position will contribute to Our Company in  Carlow site by managing, coaching, and developing a high-performing multi-disciplined team.   Bring energy, knowledge, innovation to carry out the following: We suggest 5-6 bullet points in this section: Leadership activities including selection, development, coaching and day to day management of the Technical Engineering, Validation Team whilst delivering to the site’s plan of record and business requirements. With a focus on Safety first, and quality always. To plan and manage process engineering and validation activities to support the technical transfers as well as sustaining site validation activities such as requalifications, annual reviews etc This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning, PCM, CTU mapping, filter validation, NPI and associated projects. To manage and deliver on all technical/Validation/QN/Change control/Project support within the specific technical engineering value stream; maintaining compliance with all regulatory expectations and Company policies. Identify, establish, and implement systems and practices to monitor and improve the Technical engineering value stream activities. These will include component preparation activities, SUT’s / formulation / fill/Inspection processes within the Carlow facility as applicable to the three technical engineering value streams. Sponsor and foster lean six sigma and standard work within the technical engineering value stream Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making). Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.  What skills you will need: In order to excel in this role, you will more than likely have: Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline. Green Belt preferable. Proven relationship-building skills with scientific leaders. 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. Technical. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing. Experience of executing and/or managing through equipment and process validation in a sterile environment. Good shipping/Filter/Cleaning validation knowledge required. Knowledge of QbD/CPV desirable. Excellent report, standards, policy writing skills required. Recruitment and selection experience. 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. Having a strong safety ethos. Have proven record of process improvement implementation. Business. Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner. Understand the specific responsibilities of all Carlow functions as they relate to one’s own department as well as the network governance groups. Excellent people management skills. Proven record in planning and basic project management of a team to deliver on time/schedule and cost. Proven contractor and vendor management. Strong influence skills. Have shown the ability to effectively manage complex projects across multiple disciplines. Demonstrate analytical and systematic problem solving skills. Effective time management and multi-tasking skills. Trouble shooting skills. Goal/results orientated. Excellent attention to detail. Self motivated. Flexible approach. Strong change management skills. Effective conflict resolution skills. Negotiation skills. Business acumen. Strategy planning and development. Risk management skills. Excellent facilitation and assessment skills. Have shown the ability to manage budgets and forecasts. Leadership. Focus on Customers and Patients. Collaborate on site and within the Our Company network. Act with Candor and Courage. Make Rapid, Disciplined Decisions. Drive Results & accountability within the team. Build Talent & develop our people. Demonstrate Ethics and Integrity. Strive to be innovative in how we do business. Engage with our business colleagues and learn from them as well as from our own experiences. ______________________________________________________________________________________ As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Current Employees apply HERE. Current Contingent Workers apply HERE. Search Firm Representatives Please Read Carefully  Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.  .

Date Added

926 days ago

Apply