Senior Specialist Engineering, Sterile/Liquids (Onsite)

Description – Sr. Specialist, Engineering The Sterile/Liquids Pilot Plants (SLP,) located in Bldg. 17 at West Point, is part of the Pharmaceutical Sciences organization. The SLP supports the formulation and filling of clinical, stability, and developmental supplies for vaccines, small molecules, and therapeutic proteins. The SLP interfaces with a large network including multiple of our Company's Research Laboratories teams, Sterile/Liquids Commercialization (SLC), commercial supply, and other pilot plants within the PharmSci network. SLP supplies support critical program needs related to new products undergoing process development, new products undergoing scale-up, launch, and transfer to the supply network, and existing commercial products undergoing process optimization. The Process Engineer (PE) provides technical input on sterile processes from a facility and operational standpoint, provides manufacturing project management oversight, and GMP expertise to ensure timely availability of clinical supplies and development batches to meet Clinical Development program requirements. This person is the main interface with development scientists for the activities required for the manufacturing of sterile liquid clinical and development batches in the SLP. Additional responsibilities include deviation management, process improvement projects, implementation of new technologies, and process design.

Education Minimum Requirement: Required: Bachelor's of Science in Chemical Engineering, Chemistry, Biology or related Scientific Field     Required Experience and Skills: Minimum of 3 years in a technical or operations support role Sterile process manufacturing and/or formulation development Knowledge of manufacturing equipment and Good Manufacturing Practices Project management Analytical problem-solving skills Cross functional leadership Technical writing – including batch documentation, investigations, protocols Location: West Point, PA eligibleforERP Required Skills: Adaptability, Adaptability, Analytical Testing, Batch Production Records, Biologics, Chemical Engineering, Chemistry, Clinical Manufacturing, Cross-Functional Project Management, Data Analysis, Detail-Oriented, Deviation Management, Documentation Preparation, Drug Formulations, Equipment Qualification, Functional Management, Good Manufacturing Practices (GMP), Manufacturing, Manufacturing Processes, Problem Identification, Process Design, Process Development (PD), Process Engineering, Process Hazard Analysis (PHA), Process Optimization {+ 7 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S.

Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems