Principal Process Engineer – API + OSD

BW Design Group; Boston (MA); On-site; USD 250,000 - 275,000; Full time

Benefits offered by this job

Professional development resources

Flexible work environment

Mentorship opportunities

Job summary

A leading engineering firm based in Boston is seeking a Principal Process Engineer specializing in API and OSD processes. Candidates should have over 20 years of experience, robust knowledge of FDA and EMA regulations, and strong skills in business development. The role includes leading technical projects, ensuring regulatory compliance, and optimizing manufacturing processes. A competitive salary range is offered, and the ideal candidate will thrive in a collaborative environment focused on innovative solutions.

Qualifications

• Over 20 years of experience in pharmaceutical and biologics process engineering.
• Strong skills in business development and proposal generation.
• Experience with FDA and EMA regulatory standards.

Responsibilities

• Lead client contact and stakeholder alignment.
• Design and optimize API and OSD processes.
• Manage cGMP compliance and conduct regulatory inspections.

Skills

Pharmaceutical process design

Sterilization and aseptic filling expertise

Excellent communication skills

Regulatory compliance knowledge

AutoCAD proficiency

Education

BS degree in Chemical, Mechanical, or Bio Engineering

Tools

AutoCAD

Microsoft Office

Job description

Principal Process Engineer – API + OSD

Employer: BW Design Group

Overview
You will join one of our 45 offices in the US, be part of a committed team of over 1500 professionals, and work in teams directly with clients shaping the world. As a Principal Process Engineer in our Architecture/Engineering Process Practice, you will partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

Responsibilities
- Initiate client contact and develop early stakeholder alignment based on technical competency and proactive engagement.
- Lead front‑end design programming for API and/or OSD processes requiring site survey, space programming, equipment evaluation/selection, economic analysis/justification, risk assessments, and regulatory impact reviews.
- Perform technical business development: participate in DG capabilities presentations, contribute to proposal development, author publications and white papers, and present at industry conferences or networking events.
- Serve as the leading expert for Active Pharmaceutical Ingredients (APIs) and/or Oral Solid Dose (OSD) processing operations, regulatory guidance trends, and evolving technology innovations.
- Develop API/OSD process operations: define concepts, generate client engagement/alignment, evaluate existing processes, define scale/modality appropriate solutions, align integration approach, and provide qualification strategy for traditional and emerging technologies.
- Oversee cGMP & regulatory compliance: deep understanding of FDA/EMA guidelines (USP, Annex 1) and manage inspections/deviations.
- Design and optimize API synthesis routes and unit operation sequences from laboratory through commercial‑scale manufacturing; conduct feasibility assessments, process characterization studies, and technology evaluations; establish process parameters, control strategies, and manufacturing specifications for API production.
- Design and optimize OSD process routes and unit operation sequences with the same activities as for API production.
- Lead tech transfers, optimize processes, and develop Master Batch Records (MBRs) and SOPs.
- Oversee environmental monitoring, media fills, gowning, cleaning, and root‑cause analysis for contamination events.
- Develop and deliver technical training, act as a technical lead, and provide expert support.
- Execute process system engineering from conceptual planning to final/detail design phase on wide‑range projects including system enhancements, unit operation optimization, and all‑new greenfield construction.
- Work closely with client personnel to ensure systems are designed in accordance with current Good Manufacturing Practices and develop construction documents (P&IDs, equipment drawings, piping plans, BOMs, scopes of work, etc.).
- Interface with OEMs/vendors as needed to accomplish equipment sizing and selection; develop project scopes and assist with proposal preparation for engineering/design services and complete constructed solutions.
- Stay abreast of new and emerging technologies and current Good Manufacturing Practices.

Qualifications
- Minimum 20 years of pharmaceutical and biologics process system engineering/design experience.
- Experience in proposal generation and supporting business development.
- Front‑end/feasibility study experience.
- Expertise in sterilization, aseptic filling (cartridges, vials, syringes), sealing, and handling sterile drug products.
- Working knowledge of process definition and unit operations required.
- Experience with FDA and EMA regulatory standards.
- Excellent written and oral communication, interpersonal skills, and ability to interact with team members and clients.
- Computer skills: AutoCAD (basic), Microsoft Office, and Microsoft Project (basic). Familiarity with 3D modeling, hydraulic analysis, and process simulation software are a plus.
- Willing and able to travel as necessary for project requirements (client meetings, installations, trainings, industry events, etc.).
- BS degree in Chemical, Mechanical, or Bio Engineering is preferred but other engineering degrees will be considered based on actual project experience.

Benefits & Compensation
The approximate pay range for this position is $250K – $275K. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.

We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Principal Process Engineer, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships.