Manager Project Engineering
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About this role
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, related 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 managing the justification, approval & implementation of the portfolio of projects
Prepare business case and capital investment proposals for recommend 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 managements 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. Eng 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 communications skills
Ability to understand significance of emerging technology and their application to meeting 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
Compensation and Benefits
We offer a comprehensive benefits package designed to support our employees’ wellbeing, including:
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.
Company
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