What are the responsibilities and job description for the Director of Engineering & Capital Projects position at AmbioPharm, Inc.?
Director of Engineering & Capital Projects
If you are a driven engineering professional with a passion for designing world-class pharmaceuticals facilities, we invite you to apply and be part of this exciting project! Located in North Augusta, South Carolina. Relocation is required; apply now to learn more about relocation assistance.
Position Overview:
AmbioPharm is seeking an experienced Director of Engineering & Capital Projects to lead the design and engineering efforts for a new Active Pharmaceutical Ingredient (API) manufacturing facility in the United States. This individual will oversee the full lifecycle of the project, from managing the Request for Proposal (RfP) process and selecting the design and engineering firm, to contract negotiation, project execution, and coordination between internal stakeholders and external partners.
This role requires a highly skilled leader with a strong technical background in pharmaceutical or chemical manufacturing facility design, capital project management, and regulatory compliance.
Key Responsibilities:
RfP Development & Firm Selection:
- Lead the development of the Request for Proposal (RfP) for selecting a design and engineering firm.
- Oversee proposal evaluation, selection criteria, and contract negotiations.
- Work with the CFO to ensure contractual agreements align with company objectives.
Project Management & Execution:
- Oversee and manage the full project lifecycle for the API manufacturing facility, including the following end-to-end project phases: design & engineering, construction, and commissioning & qualification.
- Coordinate multidisciplinary teams, including process engineers, civil engineers, mechanical engineers, and automation specialists.
- Ensure adherence to project timelines, budgets, and quality standards.
- Oversee facility planning, engineering design packages, and process safety reviews.
Stakeholder Coordination & Compliance:
- Serve as the primary liaison between internal teams (Operations, Quality, Regulatory, R&D, EHS) and the selected design/engineering firm.
- Ensure all design and engineering work complies with cGMP, FDA, OSHA, and environmental regulations.
- Address project risks and implement mitigation strategies.
Budgeting & Financial Oversight:
- Develop and manage project budgets, ensuring cost-effective decision-making.
- Work with finance and leadership teams to track capital expenditures and financial forecasts.
Qualifications & Experience:
- Education: Bachelor’s or Master’s degree in Chemical Engineering, Mechanical Engineering, Civil Engineering, or related field. MBA is a plus.
- Experience: Minimum 10 years of experience in engineering design, capital project management, or facility construction for pharmaceutical or chemical manufacturing, including modular construction methods.
- Industry Knowledge: Strong understanding of API manufacturing processes, unit operations, facility requirement, utilities, and automation.
- Project Leadership: Proven track record of successfully managing large-scale engineering projects, including RfP development and firm selection.
- Regulatory Expertise: Knowledge of cGMP, FDA regulations, international regulatory standards (EMA, ICH), OSHA, and environmental compliance requirements.
- Technical Skills: Proficiency in project management tools (e.g., MS Project, Primavera P6) and facility design software.
- Certifications (Preferred): PMP (Project Management Professional), PE (Professional Engineer).
Key Competencies:
- Leadership & Decision-Making: Ability to drive strategic decisions and lead cross-functional teams.
- Strong Communication: Excellent negotiation and stakeholder management skills.
- Problem-Solving: Ability to anticipate and resolve project challenges efficiently.
- Financial Acumen: Experience managing large project budgets and cost analysis.
Why Join Us?
- Opportunity to lead a high-impact capital project from inception to completion.
- Work with a dynamic leadership team in a fast-growing peptide CDMO organization.
- Competitive compensation, benefits, and career growth opportunities.