Senior Engineer, Technical Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the ThermoFisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:At Thermo Fisher Scientific, join our collaborative team as a Sr Engineer, Technical Operations, where you'll contribute to developing and manufacturing biopharmaceutical products. You'll apply your technical expertise to ensure the highest quality standards while working with advanced technologies and processes. This position offers the opportunity to work with cross-functional teams, enhance processes, and contribute to therapies that help improve global health and environmental sustainability.

You will manage technical projects, provide manufacturing support, and resolve complex process challenges while ensuring compliance with GMP regulations. Your role will involve developing and optimizing formulation processes, conducting validation studies, and working closely with clients and internal teams to deliver excellent results. This position offers professional development opportunities within our organization that values integrity, dedication, collaboration, and innovation.

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, requalification 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.
• 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.

 

REQUIREMENTS:

• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in biopharmaceutical manufacturing or related industry
• Preferred Fields of Study: Chemistry, Biochemistry, Biology, Biotechnology, Chemical Engineering, or related scientific field
• Additional certifications in Production and Inventory Management (CPIM) or related areas are beneficial
• Strong understanding of GMP regulations and quality systems
• Expertise in process validation, risk assessments, and process control strategies
• Proficiency in manufacturing documentation systems and batch record review
• Experience with technology transfer and scale-up processes
• Strong analytical and problem-solving abilities
• Excellent project management and organizational skills
• Outstanding written and verbal communication capabilities
• Ability to work effectively in a matrix environment with cross-functional teams
• Proficiency in English required; additional language skills beneficial
• Experience with relevant software systems (SAP, LIMS, etc.)
• Availability for flexible scheduling including on-call duties when required
• Demonstrated leadership abilities and mentoring skills
• Knowledge of Lean Manufacturing and Six Sigma methodologies
• Strong attention to detail and commitment to quality standards