Job Description

How Will You Make an Impact? Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com. What will you do? The Incumbent provides technical support for all the products manufactured at the site. Responsible to provide expertise in technical field, process improvements, cleaning validations, NPI (New product Introduction). Will also provide expertise in the process activities, validation, qualification activities of products and processes, re-qualification activities and quality investigations. The incumbent will report to the Manager, Technical Operations. Responsibilities

• Supports in NPI (New Product Introduction) or existing product by participating and supervising development studies, cleaning process development and qualification activities of products and processes, re-qualification activities and quality investigations.
• Demonstrate in-depth knowledge of change controls, cleaning validations, qualifications and process performance trending and reporting.
• Responsible to author technical Operations protocols, reports and other documentations related to existing product or NPI at site.
• Act as point of contact and mentor to guide junior engineers to manage NPI, quality investigation and complaints, CPV, problem solving and statistical and problem-solving tools.
• Collaborating with the managers of the production departments for the optimization of production yields, optimization of the layout and the improvement of the flexibility of the plants, development of processes and the cost minimization. All this collaboration should be with focus in compliance with the budget, customer needs, GMP and quality and safety procedures and standards of the company.
• Demonstrates expertise in good technical writing skills with respect to reports, protocols, quality investigations and change requests.
• Will be a change owner for change controls and if required a technical reviewer of the change control. Will lead significant quality investigations.
• Technical approver for quality investigations, validations/qualification protocols/reports, risk assessment, change controls and other technical documents, where applicable.
• Provide technical expertise for day-to-day production activities of commercial products, e.g. Support in identifying root causes of problems; changes and improvements to processes; implementation of new production technologies etc.
• Provides technical expertise for quality compliance activities (for e.g. documentation update to batch records, SOPs, risk assessments etc), change control, investigations and CAPA and support for health authorities' inspections.
• Proactively supervise and review Continuous Process Verification (CPV) and Annual Product Review (APR) activities to trend, monitor and analyze and adjust and shift in process parameters, critical quality attributes (CQAs) and process and equipment performance.
• Ensures the continuous improvement of the production structure, through the proposal of improvement actions related to the layout of the production plants and the flexibility of the plants, the adaptation to the Current GMP and the optimization of costs, in compliance with the assigned budget, GMP, interests, procedures and company quality standards.
• Participates in critical technical projects related to the production of commercial sterile pharmaceuticals.
• Acts as the main interface on technical issues between technical operations and customers.
• Ensures that new products/processes introduced into production are robust and efficient. It follows and supports from a technical point of view or the engineering and validation batches in order to ensure the robustness and efficiency of the transferred processes.
• Participation in project meetings, aimed at transposing the production processes requested by the customer, the approval of the instructions regarding production operations, any support in the event of anomalies with respect to production standards.
• Demonstrate and promote EHS safe practices as per safety standards SOPs. Ensure all the activities are carried out as per EHS standard and site safety SOPs. Participate in safety activities, HAZOPS and process safety activities related to the product at site
• Any other duties assigned by manager.

• Minimum Bachelor's degree in engineering, biological/chemical sciences or related disciplines

• 2 to 5 years of Pharmaceutical experience is preferred.

• Pharmaceutical manufacturing processes
• Knowledge of GMP
• Knowledge of Statistical Process Controls and related tools
• Good computer skills
• Knowledge of laws and regulations relating to safety and conservation of the environment
• Flexibility
• Leadership
• Openness and attentive
• Specific experience in the production of sterile injectable drugs is preferred
• Specific experience in packaging and visual inspection activities is preferred.
• Highly motivated to work in pharmaceutical Industry.
• Able to work as a team.