Senior Engineer – MSAT (NPI)
PCI Pharma Services
Summary
The Senior Engineer-MSAT role is responsible to define relevant operational/technical standards and practices for PCI sites that produce medical devices as well as the site and identify and drive implementation of improvements to maximize throughput and capacity utilization. The incumbent interfaces with other PCI functions as well as external clients to implement new processes and technologies into PCI GMP manufacturing as well as supporting validation efforts. The Senior MSAT Engineer is a key contributor within a group responsible for performing process improvements, including timely completion of feasibility studies, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products/devices to pre-clinical, clinical and commercial manufacturing phases.
Job description
Essential Duties and Responsibilities
- Actively participate and provide input and feedback for the PCI Safety Program to meet Health and Safety regulations and OSHA requirements in all duties
- Provide technical mentorship to junior MSAT Engineers and investigators
- Experimentation and manufacturing support related work including development and pilot scale studies to support process development, optimization and characterization
- Contributes to the evaluation of novel, generic platform technologies that can be applied across multiple programs
- Active contributor in the technology transfer of programs spanning all phases of biopharmaceutical/medical device lifecycle, including discussions of scale, equipment design and oversight of GMP and Engineering batches. Establish technical support initiatives for GMP operations in these multi-product sites
- Interacts with manufacturing operations staff, troubleshoots problems and supports their operations
- Compose technical documents (protocols, batch records) for conducting technical studies
- Interpret and execute policies and procedures. Recommend modifications to operating policies
- Function as a technical expert on equipment, systems, processes
- Lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation (commissioning, protocols, test plans, functional/detailed design)
- Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS)
- Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications
- Coordinate the work of consultants and engineering firms on development of standard design documents
- Provides technical support to external clients and internal operations, utilizing statistical data analysis. Develops solutions to complex problems using ingenuity and innovation, and ensures solutions are consistent with overall organization objectives
- Drives key equipment, systems, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule and overall project performance
- Provide technical support and analysis for the resolution of deviations, investigations, and process issues
- May be directed to independently develop department procedures, standards, and specifications; write and review data summaries as per established company guidelines and procedures
- Authors technical reports, technology transfer packages and presentations
- Contributes to regulatory submissions. Develop project scopes, schedules and budgets
Qualifications
- BS degree in an Engineering discipline with preference for Chemical or Life Sciences with 10+ years industry experience within a pharmaceutical, biotechnology/medical device or FDA/ISO regulated industry. Comparable blends of education and/or experience is acceptable.
- Resilient, can quickly move forward despite challenges
- A drive to achieve results while working with limited supervision
- Positive attitude and strong team, cross team collaboration
- Honesty, integrity, respect and courtesy with leadership and peers
- Strong commitment to conducting PCI business according to the highest legal and ethical standards, and to continually pursue excellence in the manufacturing and delivery of PCI products and services
Requirements
- BS degree in an Engineering discipline, preferably Chemical or Life Sciences
- 10+ years industry experience within pharmaceutical, biotechnology/medical device or FDA/ISO regulated industry
- Resilient and able to move forward despite challenges
- Drive to achieve results with limited supervision
- Positive attitude and strong team and cross-team collaboration
- Honesty, integrity, respect and courtesy with leadership and peers
- Commitment to highest legal and ethical standards
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.