Pharmaceutical Senior Process Engineer

The International Society for Pharmaceutical Engineering, Inc.; Columbus (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Global Edge Group seeks a Senior Process Engineer to lead process validation, technology transfer, and registration support for internal and third-party CMOs across multiple dosage forms. You will ensure alignment with quality, regulatory, and commercialization objectives throughout the product lifecycle.

Collaborating with manufacturing, quality, regulatory, development, and external partners, you will develop robust validation strategies, perform PAT/DOE studies, and guide lifecycle management

Qualifications

• Experience in pharmaceutical technology transfer, process development, validation, formulation, manufacturing, or quality operations.
• Strong knowledge of FDA regulations, cGMP requirements, and other regulatory standards.
• Expertise in process scale-up, validation, PPQ, commercialization, and manufacturing equipment.
• Experience supporting multiple dosage forms, including solid oral dosage, inhalation products, semi-solids, transdermals.
• Knowledge of DOE methodologies and statistical data analysis.

Responsibilities

• Lead process development, transfer, and validation for internal and third-party products.
• Support process registration, scale-up, validation, and commercial manufacturing activities.
• Develop validation and filing strategies, including batch sizing, sampling plans, protocol development.
• Provide technical expertise during registration, scale-up, and commercial campaigns at internal and external sites.
• Mentor junior engineers and lead cross-functional projects.

Skills

Process engineering

Cross-functional collaboration

Regulatory compliance

Problem solving

Project leadership

Education

Bachelor's Degree in Engineering, Chemistry, Pharmacy, or related

Master's Degree in related field

Ph.D. in related field

Tools

DOE methodology

Statistical analysis

Job description

Global Edge Group is recruiting on behalf of a leading pharmaceutical manufacturer dedicated to developing, manufacturing, and supplying high-quality medicines that improve patient health and well-being worldwide. Our client operates a diverse portfolio of pharmaceutical products and manufacturing operations, supporting patients, healthcare providers, and healthcare systems through innovative and reliable solutions.

We are seeking a talented and motivated Senior Process Engineer, Third-Party & Technical Services to join a dynamic technical operations team.

Position Summary

The Senior Process Engineer will lead process validation, product registration support, and technology transfer activities for both internally manufactured and third-party contract manufacturing (CMO) products. This role ensures alignment with quality, regulatory, and commercialization objectives while supporting multiple dosage forms throughout the product lifecycle.

The successful candidate will serve as a technical expert responsible for process development, scale-up, validation, commercialization, and continuous process improvement while collaborating closely with manufacturing, quality, regulatory, development, and external partners.

Key Responsibilities

Process Development & Technology Transfer

• Serve as a process and formulation subject matter expert for cGMP and FDA requirements, supporting process registration, scale-up, validation, and commercial manufacturing activities for internal and third-party products.
• Lead process development, transfer, and validation efforts for pharmaceutical products across various dosage forms.
• Act as the technical services representative for manufacturing process flow, equipment requirements, and technical assessments during project selection and execution.
• Conduct and lead technical evaluations and site visits at contract manufacturing organizations (CMOs).
• Drive gap assessments, risk assessments, and statistical analyses related to process design, scale-up, validation, and continuous improvement initiatives, including Process Analytical Technology (PAT) and Design of Experiments (DOE).
• Develop validation and filing strategies, including batch sizing, sampling plans, protocol development, and execution requirements.
• Create, review, and approve manufacturing documentation, including:
• Master Manufacturing Records
• Batch Records
• Validation Protocols and Reports
• Technical Justifications
• Process Documentation
• Provide technical expertise during registration, scale-up, process transfer, validation, and commercial manufacturing campaigns at internal and external manufacturing sites.

Regulatory & Commercialization Support

• Collaborate with Product Development and project teams to establish robust control strategies for commercial manufacturing.
• Support regulatory submissions including ANDAs, NDAs, PAS submissions, response packages, and related technical documentation.
• Partner with Regulatory Affairs to author and/or review filing documentation and support regulatory approvals.
• Contribute to Quality by Design (QbD) documentation and process development reporting.
• Evaluate registration-scale batch data and support equipment procurement or modification activities required for commercial production.

Process Validation & Lifecycle Management

• Lead planning and execution of:
• Process Scale-Up
• Technology Transfer
• Process Validation / PPQ
• Commercial Production
• Continued Process Verification (CPV)
• Serve as the primary process validation lead throughout the product lifecycle.
• Develop manufacturing strategies related to validation lots, commercial batch sizing, and launch readiness.
• Support ongoing lifecycle management, CPV programs, and revalidation activities.

Quality & Continuous Improvement

• Lead complex investigations related to process deviations, non-conformances, and manufacturing issues.
• Conduct root cause analyses and implement corrective and preventive actions (CAPA).
• Collaborate with Quality, Regulatory, Manufacturing, and Engineering teams to implement process changes and continuous improvement initiatives.
• Lead optimization efforts involving:
• Raw material changes
• API changes
• Process parameter modifications
• Batch size optimization
• Equipment enhancements
• Drive resolution of process quality and product stability issues in commercial products.

Leadership & Mentoring

• Mentor junior engineers and technical staff in process engineering, validation strategies, investigations, CAPA development, and manufacturing technologies.
• Promote knowledge sharing and adoption of best practices across Technical Services.
• Author and maintain SOPs, work instructions, and other technical standards.
• Provide technical leadership in resolving complex manufacturing, validation, and process engineering challenges.
• Perform other duties as assigned.

Qualifications

We recognize that experience comes in many forms and encourage qualified candidates to apply, even if they do not meet every requirement listed below.

Education & Experience

Bachelor's Degree in Engineering, Chemistry, Pharmacy, or a related scientific field and:

• 6+ years of pharmaceutical industry experience, or
• 9+ years of related technical experience

OR

Master's Degree and:

• 4+ years of pharmaceutical industry experience, or
• 7+ years of related technical experience

OR

Ph.D. and:

• 2+ years of pharmaceutical industry experience, or
• 3+ years of related technical experience

Required Skills & Experience

• Experience in pharmaceutical technology transfer, process development, validation, formulation, manufacturing, or quality operations.
• Strong knowledge of FDA regulations, cGMP requirements, and other applicable regulatory standards.
• Expertise in process scale-up, process validation, PPQ, commercialization, and manufacturing equipment.
• Experience supporting multiple dosage forms, including solid oral dosage, inhalation products, semi-solids, transdermals, and related technologies.
• Knowledge of process design principles, DOE methodologies, and statistical data analysis.
• Strong problem-solving, root cause investigation, and CAPA implementation skills.
• Demonstrated ability to lead cross-functional projects and influence stakeholders.
• Excellent communication, technical writing, and relationship management skills.
• Ability to travel domestically and internationally as business needs require.