Manager Project Engineering

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.  E ng   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

Salary Range: 108,000-150,000

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.