Pharmaceutical Facilities Specialist

2 weeks ago


Raleigh, North Carolina, United States Sequoia Biotech Consulting Full time


Company Overview:
Sequoia Biotech Consulting stands at the forefront of life sciences consultancy, committed to assisting organizations in navigating intricate challenges while accelerating the journey to market for vital innovations.

Our diverse team, comprising scientists, engineers, quality specialists, and business professionals, excels in enhancing product development, technology transfer, and commercial manufacturing processes.

We empower our partners with essential tools, knowledge, and expertise to optimize operations, improve quality, and ensure regulatory compliance.

Position Summary:
We are in search of a skilled Pharmaceutical Facilities Specialist to become a key member of our team. This role is crucial in supervising and managing a variety of engineering projects within the pharmaceutical sector.

The ideal candidate will possess a robust background in HVAC systems, plant utilities, or clean utilities specific to pharmaceutical manufacturing.


Facility Operations and Maintenance:
Oversee the daily operations and upkeep of pharmaceutical manufacturing facilities, ensuring optimal functionality of all systems.
Implement preventive maintenance strategies to reduce downtime and prolong the lifespan of equipment and systems.
Quickly troubleshoot and resolve facility-related issues to minimize production disruptions.

Regulatory Compliance and Safety:
Ensure that facilities adhere to all regulatory requirements, environmental laws, and safety protocols.
Conduct routine inspections and audits to detect potential safety risks or compliance issues, implementing necessary corrective measures.
Collaborate with regulatory affairs and quality assurance teams to guarantee that facilities comply with cGMP (current Good Manufacturing Practices) standards.

Sustainability and Energy Efficiency:
Introduce energy-efficient practices and sustainability initiatives to mitigate the environmental impact of facility operations.
Assess and propose energy-saving technologies and practices to enhance overall facility efficiency.

Project Oversight:
Lead facility enhancement projects, including renovations, expansions, and equipment installations.
Develop comprehensive project plans, budgets, and timelines, overseeing execution from inception to completion.
Coordinate with external contractors, engineers, and vendors to ensure timely and budget-compliant project delivery.

Documentation and Reporting:
Maintain precise records of facility maintenance activities, repairs, and upgrades.
Prepare necessary reports and documentation for regulatory bodies, management, and stakeholders as required.

Qualifications:
Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related discipline.
Extensive knowledge of HVAC systems, hydronic utilities, steam systems, building automation systems, and/or cleanroom environments.
Familiarity with cGMP regulations and guidelines relevant to pharmaceutical manufacturing facilities.
Strong project management capabilities, with the ability to handle multiple projects concurrently.
Exceptional problem-solving skills and meticulous attention to detail.
Effective communication skills and a collaborative approach in a team-oriented environment.
A Professional Engineering license (PE) is advantageous.

Salary Range: $69,000-$213,000 USD
Additional Information: Sequoia offers a comprehensive benefits package, including medical, dental, vision coverage, 401K, and company-paid life insurance.

Sequoia is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.



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