Manager Project Engineering

Bora Pharmaceuticals; Maple Grove (MN); On-site; USD 108,000 - 150,000; Full time

Benefits offered by this job

Competitive salary and performance-based incentives

Comprehensive health coverage

Retirement savings plans with employer matching

Job summary

Bora Pharmaceuticals in Maple Grove, MN is seeking a Project Engineering Lead to oversee capital equipment procurement in pharmaceutical manufacturing. This role involves managing the project engineering team and ensuring compliance with GMP standards.

The ideal candidate has an Engineering degree and 5-10 years of experience in project engineering within solid oral dose facilities. Excellent leadership and negotiation skills are essential, along with the ability to translate operational needs into engineering solutions.

Qualifications

• 5-10 years in project engineering (capital equipment related).
• Proven experience managing capital projects in solid oral dose facilities.
• Strong skills in project management, control systems, and process engineering.

Responsibilities

• Lead Project Engineering staff to develop and implement GMP manufacturing solutions.
• Manage relationships with customers, vendors, and above-site resources.
• Oversee capital projects and ensure compliance with regulations.

Skills

Project management

People management

Communication skills

Negotiation skills

Technical knowledge in OSD

Education

Undergraduate Degree in Engineering, P.E. preferred

Tools

MS Office

SAP

CMMS

Job description

About Bora

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products.

From our world‑class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora's teams, technologies, and facilities work seamlessly together to enable our clients to deliver much‑needed therapeutics to patients worldwide.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

Job Summary

Provide leadership to the project engineering team in a pharmaceutical solid oral dose manufacturing facility. Own the full lifecycle of capital equipment procurement—from initial financial modeling and vendor negotiations to engineering oversight, installation, and final cGMP qualification. Develop and mentor engineering staff.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Responsible for managing & implementing new capital projects and improvement projects
• Lead Project Engineering staff, internal resources, external engineering suppliers to develop, implement and improve GMP manufacturing and packaging related facilities, equipment and systems
• Provides engineering expertise and advice for developing technical solutions that best meets business requirements
• Translate operational needs into detailed User Requirement Specifications (URS) and technical engineering designs
• Oversee the site capital plan and manage the justification, approval & implementation of the portfolio of projects
• Prepare business case and capital investment proposals for recommended technical solutions to optimize manufacturing capability
• Forecast and manage resource needs to deliver project plans
• Communicate project status including scope, schedule, budget to stakeholders
• Lead and motivate staff to develop & deliver the optimal technical solutions that meet the business needs
• Select and manage professional consultants, contractors and suppliers
• Manage relationships with customers, vendors and above‑site resources to set expectations and communicate progress
• Ensure that compliance issues and regulatory audit questions are addressed

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience and Skills

• Undergraduate Degree in Engineering, P.E. preferred
• 5-10 years in project engineering (capital equipment related)
• Proven experience managing capital projects in solid oral dose (OSD) facilities
• Excellent people management skills
• Demonstrated interpersonal, leadership, negotiation, organization and communication skills
• Ability to understand significance of emerging technology and their application to meet business goals
• Detailed knowledge of multiple technical disciplines (including Facilities, Critical Utilities, Construction, Manufacturing, Packaging, and Computer & Automated Systems) and ability to apply these practices in addressing issues at work
• Strong skills & knowledge in: project management, control systems, equipment & process engineering and validation
• Preferred experience related to information and distributed system analysis, design, integration and implementation
• Knowledge of HPB, FDA, GAMP, IEEE & PMBOK standards
• Proficient in MS Office, SAP, CMMS and other similar software

Salary Range: 108,000-150,000

Compensation and Benefits

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.