Senior Engineer – MSAT (NPI)
About The Position
The Senior Engineer-MSAT defines operational and technical standards and practices for PCI medical device manufacturing sites and identifies and drives improvements to maximize throughput and capacity utilization. The role works with PCI functions and external clients to introduce processes and technologies into GMP manufacturing and support validation efforts. As a key contributor to the MSAT group, the Senior Engineer supports process improvement work for new biopharmaceutical products and devices entering pre-clinical, clinical, and commercial manufacturing. This includes feasibility studies, scale-up, technology transfer, process development and optimization, and support on the GMP manufacturing floor. The role also provides technical mentorship, supports manufacturing operations, leads equipment and facility improvement projects, and contributes to technical documentation and regulatory submissions.
Requirements
- Bachelor of Science degree in an engineering discipline; Chemical Engineering or Life Sciences is preferred. Comparable combinations of education and experience are acceptable.
- 10 or more years of industry experience in pharmaceutical, biotechnology, medical device, or FDA/ISO-regulated industries.
- Resilience and the ability to move forward quickly despite challenges.
- Drive to achieve results while working with limited supervision.
- Positive attitude and strong team and cross-team collaboration skills.
- Honesty, integrity, respect, and courtesy in interactions with leadership and peers.
- Strong commitment to conducting business according to high legal and ethical standards and pursuing excellence in manufacturing and delivery of products and services.
Responsibilities
- Participate in the PCI Safety Program and provide input and feedback to support health and safety regulations and OSHA requirements.
- Provide technical mentorship to junior MSAT Engineers and investigators.
- Conduct experimentation and manufacturing support work, including development and pilot-scale studies for process development, optimization, and characterization.
- Contribute to evaluating novel and generic platform technologies for use across multiple programs.
- Contribute to technology transfers across biopharmaceutical and medical device lifecycle phases, including discussions of scale and equipment design, and oversight of GMP and engineering batches.
- Establish technical support initiatives for GMP operations in multi-product sites.
- Interact with manufacturing operations staff, troubleshoot problems, and support operations.
- Compose technical documents, including protocols and batch records for technical studies.
- Interpret and execute policies and procedures, and recommend modifications to operating policies.
- Serve as a technical expert on equipment, systems, and processes.
- Lead operational troubleshooting, develop preventive maintenance procedures, and maintain engineering documentation, including commissioning documents, protocols, test plans, and functional and detailed designs.
- Establish equipment specifications in standard documentation, including User Requirements (URS), Functional Specifications (FS), and Detail Design Specifications (DDS).
- Lead work with manufacturing, process development, facilities, quality assurance, and other departments to develop requirements and recommendations for system modifications.
- Coordinate consultants' and engineering firms' work on development of standard design documents.
- Provide technical support to external clients and internal operations using statistical data analysis; develop innovative solutions to complex problems consistent with organizational objectives.
- Drive key equipment, systems, and facility improvement projects, overseeing design, construction, testing, and turnover, with responsibility for schedule and overall project performance.
- Provide technical support and analysis to resolve deviations, investigations, and process issues.
- Develop department procedures, standards, and specifications when directed, and write and review data summaries according to company guidelines and procedures.
- Author technical reports, technology transfer packages, and presentations.
- Contribute to regulatory submissions and develop project scopes, schedules, and budgets.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
