Process Engineer, Sterile/Liquids Pilot Plant at Merck · USA -…

Summary: Merck is a leading pharmaceutical company, and they are seeking a Process Engineer for their Sterile/Liquids Pilot Plants. The role involves providing technical input on sterile processes, project management oversight, and ensuring the timely availability of clinical supplies and development batches. Responsibilities: - Provide technical input on sterile processes from a facility and operational standpoint, manufacturing project management oversight, and GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements - Interface with development scientists for the activities required for the manufacturing of sterile liquid clinical and development batches in the SLP - Monitor the achievement of batch planning and execution progress compared to program timelines with sub-teams and key support functions - Perform key batch activities, such as authoring the batch record, coordinating transfer and receipt of batch inputs, providing shopfloor support during batch manufacture, and sample & batch delivery - Leverage relationships and networks to improve and enhance team dynamics, with guidance from senior team members and leads as needed - Proactively identify and escalate potential obstacles to drive business results - Prepare and facilitate key team meetings including creating agendas, ensuring appropriate participation, contributing program management insights, and following up to ensure the team continues to make progress towards deliverables - Participate in department initiatives and workstreams aimed at improving the way that we work and interact with one another - Utilize technical subject matter expertise, leverage departmental procedures, and adhere to quality and compliance requirements to execute on batch manufacturing - Own relevant change control and lead deviations, inclusive of impact assessment, root cause analysis, and CAPA identification - Implement new technologies and support process improvement projects Required Qualifications: - Bachelors of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field - Minimum of 1.5 years in a technical or operations support role - Knowledge of manufacturing equipment and Good Manufacturing Practices - Strong communication skills, both oral and written. Knows when and how to speak up and appropriately raise issues to team and to management. Keeps both team members, departmental colleagues (as appropriate), and management fully apprised of project initiative status and issues at the right level of detail - Effective interpersonal skills and ability to work collaboratively across diverse teams and networks; able to foster cooperation in others, using the diverse perspectives of others to generate ideas - Ability to succeed in a dynamic environment with flexibility to respond to changing priorities - Demonstrated ability to generate innovative solutions to complex problems and effectively work with and communicate to key stakeholders - Adaptability - cGMP Guidelines - Personal Initiative - Process Engineering - Process Optimization - Product Formulation - Standard Operating Procedure (SOP) Writing - Sterile Manufacturing - Teamwork - Technical Writing - Troubleshooting Preferred Qualifications: - Sterile process manufacturing and/or formulation development - Project management - Cross functional leadership - Change Control - Deviation Management - Strong technical writing - Electronic Batch Records - Laboratory Research - Pilot Plant Operations Required Skills: Process Engineering, Sterile Manufacturing, Process Optimization, Product Formulation, cGMP Guidelines, Standard Operating Procedure (SOP) Writing, Troubleshooting, Manufacturing Equipment Knowledge, Change Control, Deviation Management, Personal initiative Benefits: Medical, dental, vision healthcare and other insurance benefits (for employee and family), Retirement benefits, including 401(k), Paid holidays, Vacation, Compassionate and sick days