Utilities Engineer, Senior

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

 PRINCIPAL RESPONSIBILITIES:

• Responsible for Water for Injection (WFI), Purified Water, and Pre-Treatment design, preventive maintenance plans, and review and approval of corrective maintenance.
• Responsible for HVAC design and classification of cleanrooms, ensure they are maintained and compliant for Manufacture of Sterile Medicinal Products
• Ensure all work is carried out and equipment is installed in a safe, effective and compliant manner compliant with industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, Corporate Quality and EHS directives.
• Responsible for supervising the design, startup, and maintenance of both plant and clean utility systems at AGC facilities
• Computer literacy in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer-based maintenance program desirable.
• Quality – GMP experience within a pharmaceutical / or food manufacturing environment
• Develop and implement utility system strategy and engineering standards
• Drive continuous improvement and long-range planning for equipment capitalization
• Assist sites to deliver utility and expansion projects on schedule and budget
• Work closely with key customers in operations, quality, and process development to ensure regulatory compliance and utility system service levels meet requirements.
• Communicate and collaborate with technical and management staff within Operations, Engineering, MSAT, and Quality
• Promote and maintain a safe working environment for team and customers
• Support site master planning strategy to encompass utility capacity analysis, system obsolescence remediation, and standardization.
• Work with site engineering to adopt global standards
• Manage vendor contracts and relationships on a consistent basis
• Own quality records such as change controls, deviations, and CAPAs that affect facility/utilities.
• Other duties as assigned

 KNOWLEDGE, SKILLS & ABILITIES:

• Strong written, verbal and interpersonal communications skills.
• Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
• Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).
• Computer literacy in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer based maintenance program desirable.
• Demonstrated ability to work on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations to management
• Knowledgeable of operation, design, installation, and startup of key site utility systems.
• General Electrical, Mechanical, Control System knowledge.
• In-depth knowledge of documentation requirements for cGMP manufacturing.
• Demonstrated good interpersonal skills, customer focus, and professionalism.
• Ability to read, interpret, and troubleshoot engineering drawings, P&IDs, and electrical schematics. 
• Knowledge of Biologics related production equipment.
• Quality – GMP experience within a pharmaceutical / or food manufacturing environment
• Lean, continuous improvement and cost reduction methods and implementation.
• Management and development of budgets,
• Demonstrated ability to develop and maintain clear and accurate documentation of process equipment or manufacturing processes.

EDUCATION/EXPERIENCE:

• BS/MS in Engineering (Chemical, Biotechnology, Mechanical, or Electrical)
• Minimum of 8 years’ relevant industry experience required for BS candidates or 6 years’ experience for MS candidates
• Minimum of 5 years troubleshooting process automated systems in Biotech/Pharma process
• Lean / Six Sigma certification desirable
• Upstream and Downstream unit operations familiarity (centrifugation, filtration, precipitation, chromatography, bioreactors, CIP/SIP, mass flow technology, etc.) desirable.
• Experience with single use manufacturing technology operations and troubleshooting desirable.
• Experience managing a project team and delivering automation CAPEX projects.
• Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
• Equivalent education and experience may substitute for stated requirements.

Compensation range:

$108,080 to $148,610

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances 

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Salary : $108,080 - $148,610