Director, Process Specialist, GS&T

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

Job summary

IPS - Integrated Project Services, LLC is seeking a Director, Process Specialist (GST) to lead the design and implementation of manufacturing processes for pharma clients. You will guide projects from pilot through operation, supporting the corporate process and manufacturing technical services to advance strategic goals.

You will manage scope, engage with clients, and drive tech transfer and process improvement initiatives while mentoring teams toward world-class designs for life sciences

Qualifications

• 15+ years of process design experience in pharma (OSD, Aseptic, or Biologics).
• Bachelor’s degree in engineering or relevant science.
• Strong proficiency with MS Word, Excel, PowerPoint, MS Project, and Visio.
• GMP design experience.
• Knowledge of process engineering codes and standards.
• Active participation in industry organizations preferred.
• Proven experience interacting with clients and leading conceptual design.
• Ability to manage multiple projects and solve problems while meeting deadlines.

Responsibilities

• Assesses project requirements, breaks down work, and defines scope with the Project Manager.
• Writes scope of work for process and manufacturing based on reviews and client meetings.
• Supports concept development and project design.
• Prepares engineering studies and schematic designs for new systems; analyzes existing ones.
• Documents process requirements, PDs, tech evaluations, flow diagrams, capacity analyses, and equipment lists.
• Consults on tech transfer and process improvement projects.
• Maintains relationships with clients, consultants, and stakeholders.
• Promotes use of company design and production standards.
• Coordinates project documents with clients and design professionals.

Skills

Process design experience

Leadership of design efforts

Client communication

Time management

Education

Bachelor's degree in Engineering or relevant science

Tools

MS Word

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.