We are partnered with an extraordinary CDMO who have recently invested over 250 million dollars into their facility in New Mexico. The job title of this opportunity is a Senior Principal Project Engineer. You will be responsible for overseeing the design, planning, and execution of engineering projects while ensuring compliance with regulatory standards. Also, lead cross-functional teams, manage vendor relationships, and implement risk mitigation strategies. Additionally, they provide technical mentorship to junior engineers and drive continuous improvement initiatives to enhance operational efficiency and product quality.
DUTIES AND RESPONSIBILITIES:
- Oversee multiple projects concurrently.
- Showcase expertise in capital management by managing the complete project lifecycle.
- Create CAPEX proposals and obtain funding approvals, addressing project scope, cost estimates, options, timelines, and execution strategies that align with company objectives.
- Define project scope and user requirements, including conceptual design, detailed design, permitting, change controls, installation, and construction. Support site acceptance tests (SATs) and factory acceptance tests (FATs), along with start-up, commissioning, validation, training, standard operating procedures (SOPs), project closeout, and turnover.
- Develop conceptual scopes with necessary evaluations of options.
- Ensure project compliance with environmental, health, safety, and cGMP regulations.
- Adhere to state and federal regulations.
- Foster effective collaboration across all functional areas within the plant, global engineering, and local agencies.
- Demonstrate strong troubleshooting skills.
- Implement life cycle cost analysis as necessary
EXPERIENCE:
- Bachelor’s Degree in Engineering, required.
- A minimum of ten (10) years’ experience as a Project Engineer or related job title.
- A minimum of fifteen (15) years’ experience in a bio/pharmaceutical manufacturing environment, or related industry.
