Lead Recruitment Consultant - Life Sciences at Orion Group
Orion Group Life Sciences are currently recruiting a Process Engineer on behalf of our Multinational Biopharmaceutical Client based in Carlow on an initial 11-Month contract with huge potential to extend.
* This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction into Carlow. This includes but is not limited to: 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.
Position 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.
Compliance
* 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.
Process Engineering & Validation
* To lead and execute process engineering and validation activities to support the technical transfers.
Projects
* To lead and manage multiple Technical Engineering projects needed to support the business at Carlow. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross functional teams to establish scope in improvement projects at Carlow as we ramp up to a fully commercial site.
* To manage and deliver on all technical/Validation/Quality Notifications/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.
Qualification and Experience
* 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.
* 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.
* 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.
* Experience in audit preparation and execution desired.
* Having a strong safety ethos.
* 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
* Effective time management and multi-tasking skills.
* Excellent attention to detail.
* Goal/results orientated.
* Demonstrable analytical and systematic problem-solving skills.
Education
* Degree qualification or equivalent (Science, Engineering, Technical).
* Green Belt preferable.
Seniority level
* Associate
Employment type
* Temporary
Job function
* Pharmaceutical Manufacturing
#J-18808-Ljbffr