Senior Project Engineer
Kindeva Drug Delivery
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
The Senior Project Engineer leads the planning, justification, funding, execution, and startup of complex capital projects supporting manufacturing, facilities, utilities, quality, and business growth objectives. This role serves as the primary leader responsible for delivering projects safely, on schedule, within budget, and in compliance with regulatory and quality requirements.
The Senior Project Engineer partners closely with Operations, Quality, Validation, Engineering, Finance, and Executive Leadership to develop capital strategies and successfully implement projects that improve capacity, compliance, operational efficiency, and customer service. The role requires strong technical expertise, business acumen, project leadership, and the ability to influence stakeholders across all levels of the organization.
Responsibilities
- Lead complex capital projects from concept through startup, including scope development, project justification, engineering design, procurement, construction, commissioning, and operational handoff.
- Develop project business cases, capital requests, budgets, schedules, and funding strategies while maintaining accountability for project cost, cash flow, and overall financial performance.
- Partner with Operations, Quality, Validation, Engineering, Maintenance, Supply Chain, and Facilities teams to deliver projects that support business objectives while minimizing operational disruption.
- Manage engineering firms, contractors, equipment suppliers, and consultants to ensure safe, compliant, and effective project execution.
- Evaluate technical alternatives and provide recommendations that balance safety, quality, operational requirements, cost, schedule, and long-term business needs.
- Present project proposals, investment recommendations, project status, risks, and mitigation plans to site and executive leadership.
- Ensure projects are executed in compliance with applicable safety, GMP, regulatory, and company standards, including support of commissioning, qualification, and validation activities as required.
- Identify and mitigate project risks while driving timely resolution of technical, operational, financial, and schedule-related issues.
- Mentor and provide technical guidance to project team members while supporting continuous improvement of capital planning, project delivery, and engineering processes.
Qualifications
- Bachelor's degree in Mechanical, Chemical, Electrical, Industrial, Civil, or related Engineering discipline.
- 8+ years of progressive engineering and capital project management experience.
- Experience managing large-scale capital projects and multi-million-dollar capital investments.
- Demonstrated success leading capital projects from concept through startup and closeout.
- Experience managing project budgets, forecasts, and financial performance.
- Experience leading cross-functional teams and managing external contractors.
- Strong communication, leadership, problem-solving, and stakeholder management skills.
- Ability to influence decisions and drive alignment across all levels of the organization.
Preferred Qualifications
- Experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
- CDMO experience preferred.
- Experience supporting sterile fill finish, aseptic manufacturing, visual inspection, packaging, or device manufacturing operations.
- PMP (Project Management Professional) certification.
- Professional Engineer (PE) license.
- Lean Six Sigma certification.
- Experience supporting GMP commissioning, qualification, and validation activities.
California residents should review our Notice for California Employees and Applicants before applying.
Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employeesregardless of formatwithout a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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