Manager, Process Engineering & Tech Transfer

Revision Skincare; Irving (TX); On-site; USD 140,000 - 180,000; Full time

Job summary

Revision Skincare is seeking a Manager, Process Engineering to lead end-to-end technical transfers from development to commercial manufacturing and to drive scale-up, validation, and CDMO management. You will collaborate with R&D, Quality, Regulatory, and Supply Chain to ensure on-time, audit-ready transfers.

This senior role requires strong process engineering expertise in cosmetics/pharmaceutical manufacturing, cross-functional leadership, and travel up to 30% to CDMOs and production sites for

Qualifications

• Bachelor's degree in Engineering including, Chemical Engineering, Industrial Engineering, Mechanical Engineering or a related technical discipline required; advanced degree preferred.
• 7+ years of experience in process engineering, technical transfer, or manufacturing within cosmetics, OTC drug, pharmaceutical, or CDMO environments.
• Demonstrated experience leading technical transfers between CDMOs, including engineering/qualification runs and GMP validation batches.
• Strong understanding of FDA OTC monograph requirements, cGMP regulations, and process validation (Stages 1–3).
• Experience with scale-up of emulsions, creams, serums, or similar topical formulations strongly preferred.
• Experience managing raw material changes, supplier qualification, and change control for marketed products.
• Strong project management skills, with the ability to manage multiple concurrent transfer and validation projects.
• Excellent written and verbal communication skills, with the ability to convey technical information to cross-functional and executive stakeholders.
• Proficiency with process engineering and statistical tools (e.g., Minitab) preferred.
• Willingness to travel to CDMO and manufacturing sites as needed.

Responsibilities

• Lead end-to-end technical transfer of formulations and manufacturing processes between CDMOs, including transfers of new products into first manufacture and transfers of established products from one CDMO to another.
• Serve as the primary technical point of contact for CDMO partners throughout transfer, scale-up, and commercialization activities.
• Develop and execute technical transfer protocols, risk assessments, and transfer plans consistent with ICH Q8/Q10 principles and Revision's quality standards.
• Coordinate engineering/qualification runs and GMP validation batches at receiving sites, and compile technical transfer reports documenting outcomes and any process adjustments.
• Support evaluation and qualification of new CDMO partners as needed for business continuity, cost optimization, or capacity expansion.
• Lead scale-up of formulations from lab/pilot scale to commercial manufacturing scale, identifying and resolving differences in equipment trains and critical process parameters.
• Partner with Formulation Science/R&D to translate bench-scale processes into robust, reproducible commercial manufacturing procedures.
• Troubleshoot manufacturing and process deviations that arise during pilot runs, scale-up, and commercial production.
• Apply process engineering principles — mixing, mass transfer, homogenization, emulsification, and similar unit operations — to optimize yield, consistency, and manufacturing efficiency.
• Lead process validation for OTC drug products in accordance with FDA OTC monograph requirements and cGMP regulations.
• Partner with Quality and Regulatory Affairs to ensure validation protocols, master batch records, and specifications meet OTC compliance requirements.
• Support all three stages of the process validation lifecycle: Process Design, Process Qualification, and Continued Process Verification.
• Assess the technical and manufacturing impact of raw material changes, substitutions, and discontinuations on marketed products, and lead qualification of alternate suppliers or materials.
• Manage change control for formulation, process, or supplier changes affecting commercial products.
• Partner with Supply Chain and Procurement to proactively flag supply risk and support contingency or dual-sourcing strategies.
• Provide technical troubleshooting and root cause analysis for manufacturing or quality issues affecting marketed products.
• Partner closely with RCD, Quality, Regulatory, Supply Chain, and Operations to align on technical transfer timelines, scale-up milestones, and validation deliverables.
• Serve as a key partner in the Technical Services Team at Revision Skincare, led by the Project Manager.
• Communicate technical transfer and validation status to Executive Leadership.
• May supervise process engineers or technical transfer staff as the team grows.
• Develop, review, and update standard operating procedures (SOPs), work instructions, and batch records to reflect current processes and align with cGMP and internal quality standards.
• Support the Quality organization in maintaining SOPs in an audit-ready, compliant state, ensuring all changes are captured through appropriate change control.
• Ensure technical transfer, scale-up, and validation activities are documented in controlled procedures consistent with regulatory expectations.

Skills

Project management

Cross-functional collaboration

Technical leadership

Communication

Travel readiness

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Minitab

Job description

Revision Skincare is seeking a Manager, Process Engineering to lead end-to-end technical transfers from development to commercial manufacturing and to drive scale-up, validation, and CDMO management. You will collaborate with R&D, Quality, Regulatory, and Supply Chain to ensure on-time, audit-ready transfers.

This senior role requires strong process engineering expertise in cosmetics/pharmaceutical manufacturing, cross-functional leadership, and travel up to 30% to CDMOs and production sites for