Process Development Engineer (6-Month Contract)

LifeSprout•Baltimore, MD

30d•Onsite

About The Position

This hands-on role is a 6-month contract position (with potential to extend) responsible for document generation, equipment implementation, and executing process development/validation (dev/val) studies for LifeSprout’s biomaterial platform and finished medical devices. The position will focus on translating product and process requirements into scalable, controlled, and compliant manufacturing operations through robust documentation and technical execution. We are looking for a high-energy, can-do self-starter who thrives in a fast-paced environment.

Requirements

Direct GMP experience generating SOPs, Batch records, and process validation studies is explicitly required.
BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, Polymer Science, or related engineering discipline; advanced degree desirable for Principal level.
Senior level: 5+ years of relevant hands-on process development, scale-up, manufacturing engineering, or process validation experience. Principal level: 8+ years of relevant experience with demonstrated leadership of complex process development, scale-up, equipment selection, and validation programs.
Demonstrated experience using DOE, statistical data analysis, process capability concepts, and structured experimental design to optimize and characterize manufacturing processes.
Experience defining process parameters, acceptance criteria, sampling plans, and validation approaches for regulated manufacturing processes.
Experience evaluating and specifying manufacturing equipment, working with vendors, developing user requirements, supporting purchase recommendations, and supporting equipment qualification or commissioning activities.
Working knowledge of GMP, ISO 13485, process validation, equipment qualification, change control, deviation investigation, and documentation expectations for regulated product manufacturing.
Strong technical writing skills with experience generating protocols, engineering reports, validation documentation, process descriptions, risk assessments, and manufacturing procedures.
High energy, can-do self-starter with strong organizational and prioritization skills; able to work independently and manage multiple technical workstreams in a fast-paced environment.

Nice To Haves

Specific experience with polymer milling, particle size reduction, powder or particulate handling, sieving/classification, milling equipment selection, and scale-up of polymer processing operations is strongly preferred.
Experience with biomaterials, implantable medical devices, injectable or soft-tissue products, resorbable polymers, or other polymer-based regulated products.
Experience transferring processes from R&D into GMP manufacturing, including development of work instructions, batch records, in-process controls, equipment settings, and operator training materials.
Experience with statistical software, process monitoring tools, or data analysis platforms used for DOE analysis, process characterization, capability assessment, and validation reporting.
Prior involvement supporting regulatory submissions, audits, inspections, or technical responses related to manufacturing processes, equipment qualification, or validation.
Leadership experience mentoring engineers, technicians, or manufacturing personnel; stronger emphasis on technical leadership and program ownership for Principal level.

Responsibilities

Lead document generation activities, including the creation and optimization of Standard Operating Procedures (SOPs) and Batch Records in a direct GMP environment.
Drive equipment implementation through evaluation, specification, and validation readiness to support manufacturing scale-up.
Design and execute process development and validation (dev/val) studies to establish robust process windows and identify critical process parameters.
Develop process flow diagrams, process descriptions, engineering study protocols, technical reports, risk assessments, and process control strategies suitable for quality system and regulatory use.
Evaluate manufacturing equipment, tooling, fixtures, automation options, utilities, and supporting technologies; define user requirements, compare vendor options, and make clear purchase recommendations based on technical fit, scalability, quality requirements, cost, lead time, and maintainability.
Partner with equipment vendors and internal stakeholders to support equipment specification, procurement, installation, commissioning, qualification, and readiness for routine use.
Support process validation strategy and execution, including development of validation plans, protocols, acceptance criteria, sampling plans, data analysis, deviations, final reports, and ongoing process monitoring.
Troubleshoot manufacturing and process performance issues using root cause analysis, structured experimentation, and cross-functional technical review.
Collaborate with quality and regulatory teams to ensure process development, scale-up, equipment qualification, and validation activities align with GMP, ISO 13485, and applicable medical device quality system expectations.
Train and mentor manufacturing, engineering, and technical staff on process requirements, equipment operation, process controls, and documentation expectations.
Support supplier and material changes, manufacturing deviations, nonconformances, CAPAs, change controls, and continuous improvement initiatives as needed.