0540 Manufacturing Technical Specialist
The Position:
At the company, 94,000 people across 100 countries are pushing back the frontiers of healthcare.
Working together, we’ve become one of the world’s leading research-focused healthcare groups.
Our success is built on innovation, curiosity, and diversity.
We believe every employee makes a difference.
We are passionate about transforming patients’ lives.
We are courageous in both decision and action; we believe that good business means a better world.
Technical Operations is a drug product & finished goods manufacturing organization responsible for the reliable delivery of commercial portfolio & pipeline products.
The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.
This role is part of our fill finish value stream and will collaborate with frontline, quality, and engineering to provide end-to-end oversight, management, and optimization of the manufacturing processes in the Value Stream.
The Opportunity:
As a Principal Manufacturing Technical Specialist, you will support the Process & Compliance team and serve the broader Fill Finish Manufacturing organization by driving business process improvements that significantly enhance operational performance and customer satisfaction, in the areas of quality, process capability, process reliability and robustness, operational efficiency, and standard work.
You will contribute to a variety of initiatives and projects to address business challenges and unmet needs that apply across the Value Stream organization and support functions.
You will achieve this through cross-functional collaboration within 2 workstreams: Advance & Enable.
The “Advance Team” sets the conditions for new process implementation, process validation, tech transfer & launch activities, and execution of process improvement initiatives; while the “Enable Team” performs Batch Record Review, drives root cause analysis & CAPA determination, owns & improves Quality documents, defines key performance indicators and delivers business insights through data analytics & visualization.
You will be responsible for setting the strategic direction and framework of the one or multiple programs for the Fill Finish Value Stream in the areas of process development, process improvement, training, quality, and compliance.
You will manage the deliverables within the established programs and lead teams in their execution in line with the site strategy.
You will manage the development and implementation of novel approaches to solving complex operational problems while maintaining required levels of safety, quality (including regulatory compliance), and production. Provide support on projects related to manufacturing operations.
You will interpret customer functional and informational needs and turn them into data requirements, process models, and active, functioning systems. You will build analytical tools, using multiple data sources, to automate data analytics and business performance indicators.
You will own and actively manage deviations, change records, and compliance actions related to operational activities, procedures and processes.
Provide assessments on UPEs and PEs and Global Documents to identify gaps, ensure implementation plans are complete and will meet their intended purpose(s).
You will perform critical, technical and operational review and approval of documentation related to the design, validation, operation and maintenance of HTO manufacturing processes, equipment and facilities (including engineering changes, document changes, validation documentation, etc.).
Where applicable perform critical technical and operational review and approval of the actual performance of the processes, equipment and facilities as it relates to the design, start-up, commissioning and qualification of new processes, equipment, procedures and facilities.
You will implement production and large-scale manufacturing procedures to optimize processes and ensure compliance with regulatory requirements.
You will be accountable for managing key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.).
You will lead and facilitate Root Cause Analysis and Structured Problem-Solving events, to ensure unplanned/unexpected events are thoroughly investigated and the appropriate remediation actions are defined and pursued, to ultimately reduce the number of repeat/recurring events.
You will support the technical development and learning of Fill Finish and support group staff as related to process improvements, tech transfers and process resolutions.
You will review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures and processes.
You will support routine site regulatory inspections as a technical resource and Subject Matter Expert.
You will lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed.
You will provide technical support on projects related to manufacturing operations and frontline execution, including decision making authority when required or requested.
You will coach and teach technicians, leaders and peers on a multitude of topics such as Lean, Overall Equipment Effectiveness (OEE), Root Cause Analysis (RCA) and project/program management
Who you are:
You hold a Bachelor’s degree in life sciences, physical sciences, engineering or an equivalent combination of education and work experience.
You have 5+ years of progressive experience in the pharmaceutical industry.
You are a strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.
You have a proven track record of working with large datasets (both structured and unstructured), presenting that data in meaningful ways and deriving actionable insights; presenting insights back to stakeholders.
You possess a deep understanding of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in aseptic processing and production.
You have a working knowledge of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing, including knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance.
You possess knowledge of scientific and engineering principles relevant to Aseptic Process & Equipment, which includes knowledge of aseptic manufacturing processing equipment and materials, such as isolators, filling, inspection & packaging machines, and sterilization systems, as well as the associated regulatory requirements.
You are able to work independently within broad guidelines and policies, with guidance in only the most complex situations.
You are experienced in driving continuous improvement initiatives related to process, equipment, and quality systems.
You have proven experience of effective stakeholder management and strong influencing skills where there is not direct management control.
The hiring range for this position is $40-$45 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate’s geographic region, job-related knowledge, skills, and experience amongst other factors.
Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.