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Key skills for this role
Lead Engineering teams, including maintenance, calibration, metrology, and facilities operations
Build a culture of accountability, technical ownership, and urgency aligned with manufacturing needs
Establish clear roles, expectations, and performance management across the organization
Ensure facilities and engineering systems operate in full compliance with cGMP, FDA, EMA, and global regulatory expectations, own deviation investigations, CAPAs, change controls, and engineering-related quality systems
Lead facility and utility support during internal, client, and regulatory inspections
Ensure all systems are maintained in a validated state, including qualification and requalification activities
Ensure facility and equipment design supports safe handling of high-potency compounds and complex conjugation processes
Support containment strategies, environmental controls, and cleaning systems specific to ADC and bioconjugation manufacturing
Partner with MSAT and Manufacturing to troubleshoot process-related equipment issues and optimize performance
Ensure alignment between process requirements and facility capabilities
Develop and manage Engineering budgets, including maintenance, capital, and contracts
Optimize resource allocation to balance cost, risk, and operational performance
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5+ years of experience in pharmaceutical or biotechnology manufacturing, with significant experience in engineering and facilities leadership
Proven experience supporting cGMP operations, including biologics or bioconjugation manufacturing environments
Demonstrated leadership of engineering, maintenance, and facilities teams in a regulated environment
Deep understanding of GMP utilities, cleanroom design, and facility operations
Strong experience with capital project execution, including equipment and facility commissioning and qualification
Expertise in CMMS systems, asset lifecycle management, and reliability engineering principles
Strong knowledge of regulatory expectations (FDA, EMA) related to facilities and engineering systems
Ability to operate at both strategic and tactical levels, driving execution while setting long-term direction
Strong problem-solving capability with a focus on root cause and sustainable solutions
Effective communicator with the ability to influence cross-functional teams and senior leadership
FLSA : Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
Private bioconjugate and complex-biologics CDMO+CRO serving biotechnology and pharmaceutical companies from discovery through manufacturing.
Visit company websiteJobs and hiring trendsFull-time
Senior · 5+ years experience
Onsite
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