Process Engineering & Validation Expert 1 - AS

Job Title: Biomedical Engineer Scientist

Location: Milwaukee, WI 53209
Employment Type: W2 Contract | 12 Months
Pay Rate:$62.00 - $67.00/hour | Paid Weekly
Work Model: Onsite
Shift: Day Shift | 8:00 AM – 5:00 PM

Role Overview

BEPC is seeking an experienced Biomedical Engineer Scientist to support our client's product development and process engineering initiatives in Milwaukee, Wisconsin.

This is an exciting opportunity for a hands-on scientist or engineer to take product concepts from early formulation and prototyping through analytical characterization, stability testing, scale-up, and manufacturing readiness. The role will focus on developing innovative dry-format, liquid-format, and high-throughput screening (HTS) products that support drug discovery and drug development workflows.

The successful candidate will work across a variety of product formats—including tablets, mini-tablets, sachets, vials, and 24-, 48-, 96-, and 384-well plates—and collaborate with R&D, Analytical, Manufacturing, Quality, EHS, Product Management, and Automation teams.

This position is ideal for someone who enjoys combining formulation science, engineering, analytical testing, automation, and hands-on laboratory development to turn new ideas into scalable products.

Key Responsibilities

Formulation & Product Development

• Develop biochemical products in tablet, mini-tablet, sachet, vial, and HTS plate formats.
• Formulate biological buffers, salts, sugars, amino acids, cofactors, excipients, stabilizers, stress reagents, quench reagents, and related biochemical materials.
• Develop dry-plated reagents, liquid formulations, DMSO stocks, formulation-screening matrices, and focused chemical-library formats.
• Optimize powder flow, blend uniformity, compression parameters, tablet weight, hardness, friability, disintegration, dissolution, and reconstitution performance.
• Translate new product concepts into structured experiments, prototypes, and scalable processes.

Equipment & Process Development

• Operate or support tablet presses, powder blenders, solid and liquid dispensers, analytical balances, plate-handling systems, and tablet-testing equipment.
• Develop automated or semi-automated dispensing workflows for 24-, 48-, 96-, and 384-well plates.
• Establish plate layouts, dose ranges, dispensing parameters, fill accuracy, precision, uniformity, and appropriate in-process controls.
• Support process development from laboratory-scale experimentation through pilot-scale readiness.

HTS Plate Qualification & Quality

• Qualify plate sealing, barcode identification, storage conditions, shipping, reconstitution, and end-use performance.
• Evaluate freeze-thaw exposure where applicable.
• Investigate cross-contamination, carryover, evaporation, edge effects, compound adsorption, solvent compatibility, and plate-to-plate reproducibility.
• Establish appropriate quality controls and preliminary specifications for new products and workflows.

Analytical & Stability Testing

• Develop and execute analytical methods using techniques such as UPLC/HPLC, LC-MS, UV-Vis, Karl Fischer moisture analysis, pH, conductivity, osmolality, dissolution, and tablet-performance testing.
• Design and execute accelerated and real-time stability studies.
• Evaluate stability of tablets, dry plates, liquid plates, reagents, and final packaging configurations.
• Assess bottles, vials, foil pouches, sachets, desiccants, plate seals, lids, and other moisture- or solvent-barrier packaging systems.
• Analyze experimental results and use data to guide formulation and process-development decisions.

Troubleshooting & Continuous Improvement

• Troubleshoot formulation, tableting, dispensing, and plating challenges.
• Investigate issues involving poor powder flow, sticking, segregation, content non-uniformity, precipitation, evaporation, carryover, and inconsistent well dosing.
• Identify root causes and develop practical solutions that improve product quality, consistency, and scalability.
• Support process optimization, automation, and future manufacturing-transfer activities.

Documentation & Collaboration

• Prepare product specifications, plate maps, batch records, dispensing instructions, analytical protocols, development reports, and manufacturing-transfer documentation.
• Maintain clear and accurate technical records throughout development.
• Collaborate with R&D, Analytical, Manufacturing, Quality, EHS, Product Management, Automation, and other technical teams.
• Communicate technical findings, risks, recommendations, and project progress effectively to cross-functional stakeholders.

Qualifications

Required Qualifications

• PhD with relevant experience OR MS with substantial industrial experience in Biomedical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Pharmaceutics, Chemical Engineering, Biochemistry, Chemistry, Materials Science, or a closely related discipline.
• Hands-on experience in at least two of the following:
• • Dry formulation
  • Tableting
  • Powder processing
  • Biochemical reagent development
  • Automated dispensing
  • HTS plate preparation
• Experience with 24-, 48-, 96-, or 384-well plate workflows, including solid or liquid dispensing, sealing, plate maps, storage, and quality control.
• Strong understanding of powder properties, excipient functionality, solvent compatibility, moisture sensitivity, formulation stability, and packaging compatibility.
• Demonstrated experience designing and documenting formulation, analytical, process-development, dispensing, or stability studies.
• Ability to independently translate product concepts into structured experiments, functional prototypes, and transferable processes.
• Strong analytical, troubleshooting, documentation, and cross-functional communication skills.

Preferred Qualifications

• Experience with biological buffers, pharmaceutical excipients, dissolution media, LC-MS reagents, biochemical screening kits, formulation-screening plates, or chemical libraries.
• Experience with automated solid or liquid dispensers and laboratory automation/robotics.
• Knowledge of low-volume dispensing, DMSO solutions, dry-plated compounds, and plate-sealing systems.
• Hands-on experience with UPLC/HPLC, LC-MS, Karl Fischer analysis, dissolution testing, osmolality measurement, or powder characterization.
• Experience with barcode tracking, LIMS, SDF/CSV file formats, or plate-data management systems.
• Experience with Design of Experiments (DoE) or Quality by Design (QbD).
• Knowledge of laboratory-to-pilot scale-up and technology transfer.
• Familiarity with RUO product development, GLP, GMP, or ICH stability principles.

Key Project Deliverables

During the 12-month assignment, the Biomedical Engineer Scientist will help drive several important development milestones, including:

• Assessing current tableting, blending, dispensing, plating, analytical, stability, packaging, and data-management capabilities.
• Establishing standardized development workflows for tablets, dry reagents, liquid reagents, and HTS plates.
• Qualifying solid and liquid dispensing processes across relevant dose and volume ranges.
• Prototyping two to three priority products in tablet, sachet, vial, or plate formats.
• Demonstrating acceptable dose uniformity, plate uniformity, tablet performance, reconstitution, analytical quality, and stability.
• Establishing preliminary product specifications, plate maps, barcode and lot-tracking requirements, packaging recommendations, and stability plans.
• Preparing at least one product candidate for pilot-scale manufacturing or customer evaluation.
• Developing a technical roadmap supporting scale-up, automation, manufacturing transfer, and potential future RUO, GLP-supporting, or GMP-grade development.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.

With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Apply Now!

If you are a hands-on scientist or engineer with experience in formulation development, tableting, powder processing, biochemical reagents, automated dispensing, HTS workflows, analytical testing, or product scale-up, we encourage you to apply.

Please submit an up-to-date resume with specific examples of projects and accomplishments demonstrating how your experience aligns with the qualifications above. Be sure to highlight relevant experience with formulation development, HTS plates, analytical instrumentation, automated dispensing, stability studies, scale-up, and technology transfer.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.

With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.