Principal Process Engineer
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Principal Process Engineer – OSD (Oral Solid Dosage) Brooksource Engineering Services
Overview:
Brooksource Engineering Services is seeking a Principal Process Engineer to support the design, delivery, and optimization of advanced pharmaceutical manufacturing facilities, with a focus on Oral Solid Dosage (OSD) operations. This role will serve as a technical leader on capital projects, ensuring process design, equipment selection, and system performance meet business, regulatory, and operational requirements. The ideal candidate brings deep technical expertise, strong stakeholder engagement, and experience delivering GMP-compliant manufacturing solutions.
Key Responsibilities:
- Provide technical leadership and direction across process engineering activities for capital projects
- Translate business and operational requirements into robust, scalable technical solutions
- Lead technology selection, capacity modeling, and preliminary equipment sizing
- Develop and review User Requirement Specifications (URS) to ensure accuracy and readiness for validation
- Conduct and lead process risk assessments to ensure safety, quality, and compliance
- Support supplier selection, procurement activities, and bid evaluations
- Collaborate with equipment vendors, engineering firms, and construction teams to deliver integrated manufacturing systems
- Review and approve process design documents and vendor technical submittals
- Perform construction-phase technical audits and oversee Factory Acceptance Testing (FAT)
- Support commissioning, qualification, and validation (CQV) activities for GMP equipment
- Provide ongoing technical support to manufacturing sites and external partners to optimize process performance
Required Qualifications:
- Strong technical expertise in Oral Solid Dosage (OSD) unit operations (e.g., blending, granulation, compression, coating, packaging)
- Experience with GMP equipment lifecycle: specification, procurement, installation, commissioning, and qualification
- Proven ability to lead technical decision-making on complex capital projects
- Strong communication and stakeholder management skills across cross-functional teams
- Experience working with equipment suppliers, EPC firms, and manufacturing operations
Preferred Qualifications:
- Experience in large-scale pharmaceutical capital projects
- Familiarity with process modeling and capacity analysis tools
- Knowledge of regulatory requirements (FDA, EMA, cGMP)
- Experience supporting multi-site or global manufacturing operations
- About Brooksource Engineering Services
Brooksource Engineering Services delivers high-impact engineering talent and project solutions across regulated industries, including pharmaceutical and advanced manufacturing. Our teams specialize in capital project execution, process optimization, and technical consulting, helping clients bring innovative manufacturing capabilities online efficiently and compliantly.