Manager Manufacturing Systems Operations
Manager Manufacturing Systems Operations
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 108080 - 146010
1 Vacancy
Job Description
Our purpose is to bring hope to life by enabling lifechanging 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.
JOB SUMMARY
The Manager Manufacturing Systems & Operations is responsible for overseeing system ownership automation validation compliance and operational efficiency within the manufacturing organization. This role ensures that manufacturing systems are aligned with regulatory requirements optimized for efficiency and continuously improved to support business delivery and growth.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
System Ownership & Compliance
- Manage system lifecycle including implementation validation (IQ OQ PQ) and continuous improvements.
- Own facility fit and system design ensuring optimal efficiency and capacity utilization.
- Develop and maintain User Requirement Specifications (URS) for system upgrades and new implementations.
- Ensure compliance with Asset Management System (BMRAM) tracking and maintaining assets to meet site and regulatory requirements.
- Oversee MEVs Work Orders (WO) and Preventive Maintenance (PM) compliance for all manufacturing systems.
- Assess system availability and suitability for upcoming projects while ensuring compliance with 21 CFR Part 11 and data integrity standards.
Automation Data Integrity & Process Optimization
- Own system automation and controls from the manufacturing perspective ensuring compliance with data integrity (DI) requirements.
- Lead system troubleshooting risk assessments and CAPA implementation to enhance system reliability and performance.
- Work closely with IT Engineering and Manufacturing to ensure seamless integration and utilization of manufacturing systems.
- Maintain system data integrity security and audit readiness for regulatory inspections and client audits.
Leadership & CrossFunctional Collaboration
- Supervise and develop function managers across multiple manufacturing disciplines.
- Foster a culture of accountability operational excellence and continuous improvement.
- Collaborate with Quality MSAT and Operational Excellence teams to align system improvements with site goals.
- Serve as an SME for manufacturing systems during regulatory and client audits.
SKILLS
- Excellent leadership problemsolving and communication skills with the ability to influence stakeholders.
QUALIFICATIONS
Required:
- Bachelors degree in engineering Life Sciences or a related field with 8 years of experience in biopharmaceutical or CDMO manufacturing
- Masters degree in engineering Life Sciences or a related field with 6 years of experience in biopharmaceutical or CDMO manufacturing
- Strong understanding of GMP regulations 21 CFR Part 11 data integrity and validation requirements.
- Experience leading teams and driving crossfunctional collaboration in a fastpaced manufacturing environment.
- Proven track record of implementing process improvements and CAPAs to enhance system performance.
SCHEDULE
Mon Fri 8 am5 pm)
COMPENSATION
$108080 $146010
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 sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased 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 cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.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.
Required Experience:
Manager
Employment Type
Full-Time
