One of our large pharmaceutical clients located in Lansdale, PA is seeking a Project Manager - Engineering Operations to join their growing team. This team is responsible for setting up an entire new manufacturing operation for syringe and vial filing . Their core responsibilities will include scope generation, process and facility design, equipment selection, vendor interaction/management, technology transfer support, construction support, equipment qualification, and facility start-up and knowledge transfer. The equipment they will be working with will include Fermenters, Filling Lines, Tanks, Formulations, Syringe filling , CIP and SIPS. This individual will be working 4 days onsite and 1 day WFH however it will be moving to fully onsite by end of year. Other responsibilities include:.
Developing and implementing manufacturing processes for new products and overseeing all project scheduling
Optimizing existing manufacturing processes to improve efficiency and reduce costs
Manage teams to mitigate risk, allocate resources, and drive on time completion of initiatives
Collaborating with cross-functional teams to ensure smooth production operations
Conducting process audits to identify areas for improvement
Implementing continuous improvement initiatives to enhance productivity and quality
Providing technical support and troubleshooting assistance to production teams when needed
Updating SOPs, authoring protocols and completing batch record reviews
Utilizing change management system to update tasks and communicating updates to management teams
Conducting Root cause analysis for manufacturing system deviations and supporting quality investigations
Utilizing Microsoft Project for building out projects plans and scheduling timelines
Qualifications
Minimum five (5) years of experience in a pharmaceutical engineering role, such as Process-Equipment Engineering Design, Technical Operations, Single Use Technology or Sterile Operations.
Minimum two (2) years of experience with capital equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification.
Minimum two (2) years of project management and scheduling experience
Understanding of drug product equipment operation and design as it relates to primary packaging with a strong focus on product formulation and lyophilization.
Microsoft Project experience for schedule management
Bachelors Degree in an Engineering or Science related field
Pay: $100,000-$135,000 (can be flexible based on experience)
Hours: Monday-Friday, 9:00am-5:00pm
Hiring Method: Multiyear contract - After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year
Benefits: Medical, Dental, Vision and 401K plans available
Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.