Director, Process Specialist, GS&T

IPS-Integrated Project Services; Cary (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

IPS-Integrated Project Services is seeking a Director, Process Specialist to lead design and implementation of pharmaceutical manufacturing processes from pilot to full operation. The role drives process design, equipment selection, and strategy for GMP-compliant facilities.

You will manage client relationships, oversee scoping, and coordinate cross-disciplinary teams to ensure timely execution and adherence to industry standards. Travel is project-based and field-oriented.

Qualifications

• 15+ years of Process Design experience within the Pharmaceutical industry (OSD, Aseptic, or Biologics)
• Bachelor’s Degree from an accredited University or College in Engineering or relevant science
• GMP design experience
• Strong knowledge of process engineering codes and standards
• Active participation in industry organizations and client-facing engagements

Responsibilities

• Assesses project requirements and defines scope with the PM
• Writes scope of work for process and manufacturing
• Supports concept development and project design
• Prepares engineering studies and schematic design for new systems
• Documents process requirements and equipment lists
• Consults on tech transfer and process improvement
• Maintains relationships with clients and stakeholders
• Promotes design and production standards
• Coordinates document completion with clients and design teams
• Supports business development activities including proposals

Skills

Client leadership

Project management

Communication

GMP design

Process engineering

Education

Bachelor’s Degree in Engineering or relevant science

Tools

MS Word

MS Excel

PowerPoint

MS Project

Visio

Job description

Job Description

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Director, Process Specialist (GST) to join our GS&T (Global Strategy & Technology) team.

In this role, you will be responsible for designing and implementing manufacturing processes, equipment, and plants (from pilot to fully operational). You will also play a key role in the corporate process and manufacturing technical services and programs to support the corporate strategic plan.

Position Responsibilities

• Assesses the requirements of a project, breaks a project into tasks, and works with a Project Manager to determine the scope of work.
• Writes scope of work for process and manufacturing based on preliminary reviews and meetings with the client.
• Supports concept development and project design.
• Prepares engineering studies and schematic design for new systems and analyzes the operation of existing systems.
• Documents project process requirements including process descriptions, technology evaluations, process flow diagrams, capacity analysis, and equipment list.
• Consults for specialized projects such as tech transfer and process improvement.
• Maintains satisfactory relationships with clients, consultants, and other vested interests.
• Promotes use of and participates in the development of company design and production standards.
• Coordinates all aspects of project document completion within the company and externally with clients and other design professionals.
• Supports business development activities, occasionally (e.g. proposals/presentations).

Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights!

Qualifications & Requirements

• 15 + Years of Process Design experience within the Pharmaceutical industry working with (one or all) oral solid dosage (OSD), Aseptic, or Biologics.
• Bachelor’s Degree from an accredited University or College, in Engineering or relevant science.
• Strong proficiency in office software, including MS Word, Excel, Powerpoint, MS Project, and Visio.
• GMP design experience.
• General knowledge of system design and applicable codes in process engineering.
• Active participation in industry organizations and related initiatives is strongly preferred (for example: speaking engagements, presenting at industry events and conferences, etc.).
• Proven experience interacting and communicating directly with clients and leading conceptual design efforts.
• Has a demonstrated ability to manage projects, problem solve, communicate effectively to all key personnel, time manage, and the ability to work on more than one project at a time.

Context, Environment, & Safety

• Travel based on the project location.
• This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.

All interviews are conducted either in person or virtually, with video required.

About Us

IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.

Specialties

Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.

All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.