Technical Support Specialist

8-10 years
25 days ago
Job Description

Job description

Education Background:

. Bachelor Degree or Master Degree in technical field or industry equivalent experience or similar education background.

. Education/training of cGMP regulation. cGMP

. Fluent in written and reading English.

Professional Experience:

. Demonstration of 8 years or above subject matter expertise in aseptic production technical area, in pharmaceutical industry or in life science industry. 8

. In-depth knowledge & experience in overall DFP aseptic production equipment & process flow aspects, including following high-speed & automated systems: Filling, Formulation, W&S, Inspection, remote control system design/research/development & application, material automatic transformation system design/ research/development & application, Equipment AI, Big Data system research/development & application, equipment & system validation, etc. ////

. Proven in-depth expertise & primary leadership in mentoring/coaching/development, design & change management, planning/organizing, managing execution, and revising the work plan for complex problems solved by task force from cross functional/cross areas/cross sites.

. Rich experience driving process design/improvements using systematic methodologies lean and six sigma skills are strongly preferred.

. Working independently in cross functional team environment, while handing specialist tasks of high complexity which critical contribute to Area/Site/DFP business target & strategy. //

Purpose of the Job:

AP Technical Support specialist is overall responsible for relevant automatic & intelligent system design/research/development/implementation & improvement of AP all equipment & process, also responsible for managing projects to ensure delivering according to project plan. And also need to cooperate & coordinate with global supplier for technical innovation development, collaboration & exhibition, etc.

//

AP Technical Support Specialist need to involve AP & STJ strategy setup & execution, to meet STJ & DFP, PS business target & long-term strategy development.

AP Technical Support Specialist will on behalf of STJ AP to involve or lead cross site/DFP/PS high-level collaboration of specialist group, for cross site net work & sharing platform setup & driving, which play most key role in technical innovation & strategy development of whole DFP, even PS.

The AP Technical Support Specialist is critically impact & contribute for the following indicators of all AP core equipment & process flow - W&S, Formulation, Filling, inspection:

. Line Capacity & Stability

. Scrap Rate & First Pass Yield

. Spare Parts Control

. Green Reality Development & Roadmap Green Reality.

. Hoshin_Kanri

. Product Transfer

. MTBR/MTTR

. OEE3 & L/H Level

. Work order completion

. Validation

. Compliance

Main Job Tasks :

. Responsible for providing aseptic technical expertise on equipment & process flow.

. Responsible for resolving technical needs and driving improvement opportunities.

. Responsible for assisting technical by providing non-conformity support.

NC

. Responsible for coaching and leading investigations for technical-related issues.

. Acts as a maintenance advocate, coordinating daily schedule, removing barriers and enabling maintenance to run optimally.

. Serves as coach and technical mentor for Equipment & Process Owner, maintenance teams and relevant process teams.

. Real time Coaching/mentoring of engineers/professionals in maintenance & technical aspects:

:

o FIT/MWD

.

o Preventative and Predictive maintenance standards

o Maintenance role cards

.

o Technical systematic problem solving

o Execute process confirmation of maintenance standards used on shift and work with maintenance & process team to find ideas to proactively improve quality and compliance

o Coordinate relevant technical & process training

&.

. Ensure continuous development of aseptic production area quality and principles by systematic collection of knowledge and standardization of technique and validation and supported by cLEAN tools:

cLEAN

. Ensure Knowledge exchange across departments, projects and sites

. Develop and update relevant tools, methodologies and training materials

. Stay updated on latest developments within technique, validation and Lean principles from internal and external sources.

. Automatic system & equipment design/research & development

&/

. Lead or participation in STJ project group or DFP project groups of projects which will be transferred to STJ.

DFP.

. Lead or Participation in mechanical & automation system design robustness challenge meeting, in STJ or DFP.

STJ DFP

. Recommendation & management of specifications optimization.

. Design of test setups.

. Lead or participation in production maturing, optimization & development activities.

. Planning and follow-up of activities with subcontractors, consultants and designers.

. Take the role of Subject Matter Expert.

o Present process during audit & inspection. Guide audit tour on shop floor. Coordinate with department fulfil audit request. Support to answer questions during audit and inspection.

o Ensure global SOP & GMP requirements implementation. Review documentation and do gap analysis for SOP and reports to ensure compliance.

SOPGMPSOP

o Coaching on compliance and train engineers on process knowledge. Identify compliance gaps in responsible process, share finding s and new regulation requirements.

o Review NC/CR and give inputs. Provide professional idea to continuous improvement. Share best practice across sites.

NC/CR

. Coach/mentor process coordinators, engineers, and technicians in resolution of MTTR, MTBF, ramp-up following PM1, function BCO time, Ramp-up, and maintenance/technical.

/ MTTRMTBFPM

. Coach/mentor/teach process coordinators, engineers, and technicians in reliability management system activities.

. Execute on shift maintenance plan, review and close work orders.

. Quickly flexes to changes in the work environment and is able to prioritize business needs with grace and ease.

. Looks for common goals. Demonstrates behavior consistent with for me to win the team must win beliefs.

. Demonstrates a disciplined, systematic approach to problem solving that is based on data and facts.

. Builds strong working relationships within the team and with other departments

. Observes and enforces all safety and environmental requirements

. Models the NNWay

. Performs other duties as required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.

About
Job Source: www.novonordisk.com

Novo Nordisk A/S is a Danish multinational pharmaceutical company headquartered in Bagsv&#230&#x3B;rd, Denmark, with production facilities in eight countries, and affiliates or offices in 5 countries. Novo Nordisk is controlled by majority shareholder Novo Holdings A/S which holds approximately 25% of its shares and a supermajority (45%) of its voting shares.

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