Job Description An amazing opportunity has arisen for a Shift Technical Lead at our state-of-the-art facility for the manufacture of commercial large-scale drug substances.The Shift Technical Lead will be responsible for overseeing and guiding the technical operations during assigned shifts within the downstream production environment. This exciting role is critical in ensuring that production processes are efficiently managed, quality standards are upheld, and that the team operates in a safe and compliant manner. What you will do:Bring energy, knowledge, innovation, and leadership to carry out the following:Guide and mentor a team of bioprocess associates, facilitating training and development initiatives that enhance skills and productivity. Provide hands-on technical support and direction to address operational challenges and ensure timely resolution of issues. Troubleshoot technical issues promptly, working closely with quality and engineering teams to identify root causes and implement corrective actions. Be responsible for all scheduled activities in Downstream Operations as per the standard work plan and real-time schedule, ensuring that production targets are met effectively. Be able to speak to downtime, develop recovery plan and work with finite scheduler on updating production schedule. Manage the process, supporting area leads as needed ensuring oversight/ guidance for managing process issues. Ensure clear, complete handover to incoming technical lead to ensuring seamless continuity. Participate and provide guidance to the team in continuous improvement projects aimed at optimizing production efficiency and reducing downtime. Ensure compliance with Good Manufacturing Practices (GMP) and contribute to internal audits and inspections as required. Write comprehensive quality deviation reports, analysing the causes and impact of deviations, including human error, and developing corrective and preventive action plans. Conduct batch record reviews to verify compliance with established standards, ensuring completeness, accuracy, and adherence to regulatory requirements. Close out Manufacturing Orders (MOs) and Equipment Specifications (ESPs) in the MES system, ensuring all data is accurately reflected and documented. Oversee safety practices within the production area, ensuring compliance with all safety protocols and regulations. Promptly report any safety issues and incidents in the Enablon system, maintaining accurate records and following up on corrective actions to ensure they are closed out in a timely manner. In order to excel in this role, you will more than likely have:Bachelor’s degree in Engineering, Biotechnology, or a related field (preferred)Minimum of 5 years’ experience in a large-scale biologics manufacturing facility. Thorough knowledge of current Good Manufacturing Practices (cGMP). In-depth working knowledge of Downstream unit operations including chromatography, filtration, UF/DF, viral inactivation, column packing, BDS filling, buffer preparation, etc. Proven problem-solving skills with the ability to think critically and act decisively under pressure. Excellent communication, interpersonal, and team-building skills. Excellent focus and attention to detail. Proficient in technical documentation and reporting. As a company, we are committed to 'Inventing for Life' in all that we do. 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.So, if you are ready to:Invent solutions to meet unmet healthcare needs, please apply today.Current Employees apply HERECurrent Contingent Workers apply HERESearch 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: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:04/4/2025*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.