Senior Specialist, Bioprocess & Technical Engineering

Job description

Job Description We’re looking for a Senior Specialist in Bioprocess & Technical Engineering to join our team and make a significant impact on our manufacturing network. This is a key leadership role where you will have the opportunity to shape how complex biological processes are introduced, scaled and improved. You will work with our internal sites and external partners to enhance our technical capabilities, ensure our facilities are ready for new technologies and lead initiatives that directly support the quality and supply of life-changing products for patients. Our team thrives on technical excellence, collaboration and a shared commitment to making a difference. We work closely with teams across Manufacturing, Science & Technology, Quality and Engineering to solve challenges and ensure our processes are robust and efficient. In this role, you will report to the Director of Bioprocess & Technical Engineering and play a vital part in setting high standards across our network. Bring energy, knowledge, innovation to carry out the following: Lead facility-fit and manufacturing readiness assessments by evaluating new products against existing site capabilities, identifying facility, equipment sizing, utility and operational constraints, and defining strategies to enable successful technology transfer and commercialisation. Develop and own process mass balances and capacity models to assess manufacturing feasibility, technology requirements, equipment utilisation, buffer and media demands, and end-to-end process performance across the product lifecycle. Drive technology identification and platform alignment by evaluating process technologies, manufacturing strategies, and equipment solutions that support robust, scalable and standardised biologics manufacturing across the network. Establish and champion platform technology standards by defining, implementing, and governing manufacturing platforms, process design principles, and engineering best practices to maximise consistency, transferability and operational excellence. Support the development and deployment digital engineering tools and models that enable data-driven decision making for facility fit assessments, mass balance development, capacity planning, equipment selection, technology transfer readiness, and lifecycle management. Provide technical leadership and mentorship to internal teams and external partners, ensuring engineering solutions are scientifically sound, operationally sustainable, compliant, and aligned with platform strategies. Support/lead cross-functional technical assessments and investigations supporting new product introductions, technology transfers, process changes, and manufacturing optimisation initiatives, utilizing structured problem-solving methodologies to identify root causes and implement effective solutions. Drive continuous improvement and innovation through the development of engineering standards, digital capabilities, knowledge management systems, and scalable approaches that improve transfer success rates, reduce complexity, and enhance manufacturing robustness. Shape the future manufacturing network by contributing to technology roadmaps, facility expansion strategies, capital investment decisions, and technical due diligence activities for new products, emerging technologies, and strategic partnerships. Foster a culture of engineering excellence by promoting technical rigor, knowledge sharing, accountability, innovation, and continuous learning across the organisation. What skills you will need: In order to excel in this role, you will more than likely have: A Bachelor’s degree in engineering, biological sciences or a related field, with at least seven years of relevant experience in engineering, manufacturing or technology transfer. A minimum of 7 years of experience in biologics drug substance manufacturing, with a background in facility design, process engineering or commercial manufacturing support. A strong technical understanding of biologics manufacturing processes, equipment and automation. The ability to lead and influence in a collaborative, cross-functional environment. Excellent communication skills, with the ability to explain complex technical ideas to a variety of audiences. A talent for connecting technical details to broader business goals, such as supply reliability and quality. An inclusive leadership style that helps create a psychologically safe and accountable work environment. Experience with Good Manufacturing Practices (GMP) environments, quality systems and change control. Strong problem-solving, organisational and prioritisation skills. Preferred experience:Experience in monoclonal antibody drug substance manufacturing. Expertise in upstream or downstream biologics process engineering. Familiarity with new product introductions, Process Performance Qualification (PPQ) and lifecycle management. Knowledge of continuous improvement methods like Lean Manufacturing or Six Sigma. Experience with global regulatory requirements and supporting health authority inspections A willingness to travel up to 20% may be required. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world. Please feel free to speak to us about what flexibility means to you during your application. So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today. Required Skills: Clinical Manufacturing, Commercialization, Data Analysis, Influencing Skills, Investigation Management, Manufacturing Scale-Up, Process Engineering, Regulatory Compliance, Root Cause Analysis (RCA), Stakeholder Management, Strategic Thinking Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 09/29/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.