Staff Process Engineer

HRM Search Partners; Iowa; Presencial; USD 140.000 - 180.000; Jornada completa

Descripción de la vacante

HRM Search Partners is representing a pioneering biotechnology client seeking a Staff Process Engineer (Technical Leader) to drive scale-up, tech transfer, and process improvements across TPM/CMO networks. This senior role requires leading trials, method transfer, and cross-functional collaboration to deliver GMP-ready manufacturing processes.

You will partner with R&D, Quality, and Supply Chain, traveling to TPM sites in the Midwest, while protecting IP and optimizing costs.

Formación

• Bachelor's degree or higher in Chemical/Biochemical/Bioprocess Engineering or related field.
• 8-10 years of process engineering experience in a food biotech, specialty ingredients, or food manufacturing setting.
• Experience in GMP/food-grade environments; scale-up and tech transfer to commercial manufacturing.

Responsabilidades

• Lead scale-up trials at TPM sites from protocol development to execution, data analysis and reporting.
• Execute technology transfer packages, including process descriptions, CPPs, equipment checks and change control.
• Act as primary on-site technical lead during scale-up campaigns and technology transfers.
• Translate analytical and process test methods from R&D to TPM QC/manufacturing; validate methods and train staff.
• Define transfer protocols and acceptance criteria; sign-off at TPM sites.
• Maintain a robust GMP test method library for commercial manufacturing.
• Support pilot-scale development with CROs and university partners; define SOW and oversee execution.
• Serve as technical representative in CRO/university partnerships; review deliverables and ensure alignment.
• Manage IP/confidentiality in pilot partnerships; protect background IP before disclosure.
• Drive COGS reduction through process optimization, yield improvements and SPC implementation.
• Lead process and product improvement trials at TPM sites (heat treatment, packaging, rework, downstream).
• Analyze manufacturing data to identify opportunities; translate findings into validated changes.
• Collaborate with Quality, R&D, Commercial and Supply Chain to align operations with specs.

Conocimientos

Scale-up leadership

Data analysis

Problem solving

Communication

Vendor & partner management

Cross-functional collaboration

Project prioritization

Educación

Bachelor's degree in Chemical Engineering

Descripción del empleo

Our client is a pioneering biotechnology company operating at the intersection of science, innovation and product development. The business is combining artificial intelligence, genomics and peptide science to discover and develop natural bioactive ingredients with clinically relevant health benefits. Their mission is to improve the lives of billions of people by unlocking the power of peptides and bringing scientifically validated ingredients into everyday products, and they are hiring a Staff Process Engineer (Technical Leader) to join their growing business.

This is a technically senior role within the Operations and Engineering team, and the successful candidate will be joining at a very exciting and pivotal stage of the company's growth. The role will be responsible for leading scale-up trials, technology transfer execution, test method translation and pilot scale development across their Contract Manufacturing Organization (CMO)/Third Party Manufacturing (TPM) and Contract Research Organization (CRO)/university partner network.

The Role

• Lead execution of commercial scale-up trials at TPM sites - from trial protocol development through on-site execution, data analysis, and formal reporting.
• Execute technology transfer between TPMs in line with directed strategy: develop and implement tech transfer packages including process descriptions, critical process parameters, equipment comparability assessments, raw material qualification, and change control documentation
• Act as primary technical representative on-site during scale-up campaigns and technology transfer trials.
• Own the translation of analytical and process test methods from R&D lab scale to TPM QC and manufacturing teams, including method validation, equipment equivalence, and TPM analyst training.
• Collaborate with R&D and Quality to define method transfer protocols and acceptance criteria; lead execution and formal sign-off at TPM.
• Maintain and develop the the business test method library for commercial manufacturing, ensuring methods are robust, documented, and fit for GMP use.
• Support the business' pilot scale development programme at external CROs and university partners from project scoping and SOW definition through execution oversight and output translation into commercial readiness.
• Act as the business' technical representative in CRO and university partnerships: provide process direction, review deliverables, and ensure outputs are aligned to commercial scale-up requirements.
• Manage IP and confidentiality obligations within pilot scale partnerships in coordination with legal; ensure the business' background IP is protected before any technical disclosure.
• Drive COGS reduction through process optimisation, yield improvement, and implementation of Statistical Process Control across commercial manufacturing operations.
• Lead process and product improvement trials at TPM sites: heat treatment validation, packaging upgrades, rework programme implementation, and downstream processing enhancements.
• Analyse manufacturing data to identify improvement opportunities; translate findings into validated process changes with clear COGS or quality impact.
• Collaborate with Quality, R&D, Commercial, and Supply Chain to ensure manufacturing operations are aligned to product specifications and business objectives

Key Requirements

• Bachelor's degree or higher in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Food Science, or a closely related discipline
• 8-10 years of process engineering experience in a food biotechnology, specialty ingredients, or food manufacturing environment; demonstrated progression to senior technical responsibility.
• Hands-on experience with upstream and downstream processing (centrifugation, filtration, spray drying), and associated unit operations at pilot and commercial scale.
• Demonstrated experience working in or alongside GMP/food-grade manufacturing environments; familiarity with batch records, deviations, CARs, CAPAs, and change control processes.
• Experience supporting or leading scale-up from lab or pilot scale to commercial manufacturing, including tech transfer and trial execution at contract or third-party manufacturing sites.
• Strong data analysis and problem-solving skills; comfortable working with process data to identify root causes and drive improvements.
• Willingness and ability to travel to TPM sites in the Midwest on a regular basis.
• Self-starter with the ability to manage multiple concurrent priorities in a fast-moving, commercially driven environment.
• Strong communicator with the ability to build trust and influence outcomes with external partners (TPMs) and internal cross-functional stakeholders.
• Practical, problem-solving mindset with a bias for action; brings solutions rather than problems and drives issues to closure
• Curious and ambitious; excited by the opportunity to make a significant commercial and scientific impact in a high-growth biotech environment