Engineer I, MSAT

ElevateBio•Pittsburgh, PA

11h

About The Position

As a Process Engineer for Manufacturing Science and Technology (MSAT), you will provide process science support for GMP manufacturing, technology transfers, development studies, characterization, validation, and continuous improvement projects within a highly matrixed cross functional team for manufacturing programs. The primary responsibility is to the be Subject Matter Expert (SME) for manufacturing processes. Additionally, you will write product impact assessments, root-cause analysis reports, sampling plans, technical reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, qualification, and validation to meet regulatory requirements.

Requirements

BS/MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+/3+ years of relevant experience
Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture, and process development
Practical expertise with cGMP manufacturing and regulatory regulations and requirements.
Drug manufacturing experience required.
Understanding of process development, validation, and lifecycle management to support comparability studies, process validation, and licensure changes
Highly experienced with leading investigations, writing, deviation reports, change controls, and corrective actions
Ability to share complex principles of knowledge to others (team member, stakeholder, external, or inspection) along with strong technical writing abilities
Experience working in cross functional teams to obtain project deliverables
Knowledge of data management tools and statistical process controls

Nice To Haves

Use of LOVO, Sepax, Rotea, CliniMACs devices, automated fillers preferred.
Certified Quality Engineer, Six Sigma Green Belt, Six Sigma Black Belt or similar is a plus

Responsibilities

Represents MSAT on project teams as technical subject matter expert (SME) for drug product manufacturing.
Working cross-functionally across Process Development, Manufacturing, Supply Chain, Regulatory Sciences and Quality to provide technical assessment for technology transfers and process changes in a cGMP environment.
Work with external clients as a part of cross functional project team member to successfully tech transfer manufacturing process to cGMP environment.
Authoring and reviewing technical documentation related to manufacturing activities including protocols, technical reports, manufacturing batch records, SOPs, change controls, deviations, regulatory submissions, and product impact assessments.
Provide on-call or on the floor technical SME support for troubleshooting issues during cGMP manufacturing.
Assist in the root cause determined of process related deviations in a timely and conclusion manner. The Candidate will work with a cross functional team to resolve complex problems and deviations using experience and the efficient application of scientific methodology and technical reasoning. This position may execute experiments and perform data analysis to resolve specific deviation questions, prepares technical reports and occasionally proposes comprehensive process solutions and improvements.
Support gap analyses and risk assessments to support the capital projects and tech transfers.
Assist in execution of Process Validation activities including authoring protocols and reports.
Assist in development of data-based process performance monitoring systems.
Perform process data-driven deviation resolution and improvement projects.
Identifies and proposes continuous process improvements to management. The candidate will execute and occasionally leads complex process and procedural changes to improve drug product manufacturing process performance, robustness, productivity, safety, and efficiency.
Design studies, author protocols and reports, for process characterization and validation studies
Participate in evaluation of new technology and process automation for introduction into GMP manufacturing
Support implementation of projects at site level with Quality Assurance to ensure on-time creation and lifecycle management of MSAT systems and procedures required for the Quality Management System (technology transfer, comparability, process controls documentation, process performance review, etc.)