Staff Process Engineer

HRM Search Partners; Iowa (LA); On-site; USD 150,000 - 210,000; Full time

Job summary

HRM Search Partners is assisting a biotechnology company on a Staff Process Engineer (Technical Leader) role. The position leads scale-up trials, technology transfer and pilot scale development across TPMs, CROs and university partners, translating methods from R&D to manufacturing with a strong emphasis on GMP readiness.

The successful candidate will own method transfer packages, supervise on-site campaigns, optimize processes to reduce COGS, and collaborate with R&D, Quality, and Supply Chain

Qualifications

• 8-10 years of process engineering experience in a food biotechnology, specialty ingredients, or food manufacturing environment.
• Experience working in GMP/food-grade manufacturing environments with batch records, deviations, CAPAs, and change control processes.
• Experience leading scale-up from lab or pilot to commercial manufacturing, including tech transfer and trials at contract or third-party sites.
• Strong data analysis and problem-solving skills; able to translate process data into improvements.
• Willingness to travel to TPM sites in the Midwest on a regular basis.
• Self-starter with ability to manage multiple priorities in a fast-moving, commercial setting.
• Strong communicator with external partners and internal stakeholders.

Responsibilities

• Lead execution of commercial scale-up trials at TPM sites, from protocol development to on-site execution, data analysis, and reporting.
• Execute technology transfer between TPMs, developing transfer packages with process descriptions, CPs, equipment comparisons, and change controls.
• Act as primary technical representative on-site during scale-up campaigns and technology transfers.
• Translate analytical and process test methods from R&D to TPM QC and manufacturing teams, including validation and training.
• Collaborate with R&D and Quality to define transfer protocols and acceptance criteria; lead on-site sign-off at TPM.
• Maintain and develop the test method library for commercial manufacturing, ensuring GMP readiness.
• Support pilot scale development with CROs/university partners from scoping to translation into commercial readiness.
• Protect background IP and manage confidentiality in pilot partnerships with legal.

Skills

Data analysis

Problem-solving

Communication

Travel willingness

Cross-functional collaboration

Education

Bachelor's degree or higher in Chemical Engineering, Biochemical Engineering, Bioprocess Engineering, Food Science, or related discipline

Job description

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