Senior Specialist Engineering, Sterile​/Liquids; Onsite

Sr. Specialist, Engineering – The Sterile/Liquids Pilot Plants (SLP)

The SLP is located in Bldg. 17 at West Point, 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 Pharm Sci network.

The 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: 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 in 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, procedures.

• 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

Preferred additional qualifications and experience are welcomed.

Location:

West Point, PA. Eligible for ERP.

Employee Status:
Regular. Relocation:
No relocation. VISA Sponsorship:
No. Travel Requirements:
No Travel Required. Flexible Work Arrangements:
Not Applicable. Shift: Not Indicated. Valid Driving License:
No. Hazardous Materials: n/a.

Salary range for this role is $ - $. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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,…