Senior Process Scientist (MFG 6.1 Upstream)
The Senior Process Scientist (MFG 6.1 Upstream) will play a pivotal role in establishing the Manufacturing Technology team, with responsibility for providing engineering support to the ongoing requirements for Manufacturing 6 and 7 as well as supporting any future tech transfer projects into MFG 6 & 7.
This role focuses on process monitoring, troubleshooting, including leading/supporting major process investigations at the request of business, implementation of cost reduction projects, facility and equipment design specification.
A core function of the role will ensure on-going optimization of the manufacturing process from ideation to execution whilst providing day-to-day support to the manufacturing shift teams to ensure manufacture of product in accordance with schedule, ensuring a supply of high quality biologic products meeting our company priorities.
Responsibilities
* For new project introduction or feasibility fit assessment, work closely with MSAT, PM, BD and/or BDM department with minimal supervision from area AD and MFG lead.
* Interface with the project teams / cross-function team to ensure the manufacturing facility will operate as per the user requirements.
* Within the MFG department, lead the project related document preparation including, but not limited to MBR.
* Review all project related documents with cross-department, identify gaps and provide solutions.
* Support cross-function (MSAT, SCM, etc.) for the introduction of new or alternate consumables or raw materials for project material readiness.
* Provide expertise to the manufacturing area Associate Director (AD) and ensure all necessary plans are executed and delivered on time for all clinical and commercial stage production.
* Implement equipment CAPAs and performance improvements,
* Conduct Investigation Trending as required
* As Deviation owner or investigation lead, ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented.
* Write equipment assessments to support investigation closure.
* Change Control write up and close out.
* Coach production personnel in manufacturing equipment as required for project or process related technical training.
* Lead project summary or campaign summary, lesson learn & sharing.
* Developing and maintaining a database for investigations, or other required department tracking and data analysis needs, as applicable
* Provide equipment technical support and troubleshooting.
* Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit.
* Lead / provide Subject Matter Expert (SME) input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations including authoring investigation reports, technical assessments and summaries.
* She/he will work closely with the manufacturing area shift lead and team ensuring any actions and plans are clearly accounted for and carried out in alignment of plant operations plans.
* Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state.
* Provide routine Automation support, troubleshooting and maintenance.
* Drive the use of PI to provide business efficiency.
* Coach manufacturing team with manufacturing area ADs supervision on OpEx tools and use OE systems as the basis for identifying improvements.
* Identify equipment improvement projects for Core Engineering Unit.
* Work with the portfolio management process to identify projects/support demands from the Core Units.
* Implement and support continuous improvements that reduce cycle times and operational costs.
* Champion and drive the implementation of Global Requirement Program tools and techniques within the Operation Unit.
* Complete biennial review and PQS updates.
* Perform all duties in accordance with cGMP requirements, SOPS's and controlled documents.
* Will be flexible to take on additional tasks and responsibilities at the discretion of the Technical Operation Lead (or Manufacturing area AD).
* Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
About You
* The ideal candidate for this position will have the following:
* Qualifications: Third level qualification in a Science or Engineering related subject is preferable. A postgraduate qualification in an engineering or science discipline would be advantageous.
* Knowledge/Experience: Minimum of 8 years experience in a large-scale in a Biopharmaceutical/pharmaceutical facility.
* Ideally, experienced in establishing a Manufacturing Technology team in a greenfield context of similar size and scale.
* Excellent communication skills including computer literacy and ability to work independently and in a team.
* Thorough knowledge of current Good Manufacturing Practices (cGMP).
* Experience and knowledge of DeltaV MCS platform preferred.
* Familiarity with Chromatography and Ultra filtration production operations is desired.
We offer
* Problem Solving
* Analytical skills
* Attention to Detail
* Bonus
* Canteen
* Parking
* Pension
* VHI