OT/ICS Cybersecurity Engineer at ST Engineering securing operational technology systems. Collaborating on complex cyber security solutions and addressing security risks to critical infrastructure.
About the role
- Process Engineer III at Just Evotec Biologic supporting upstream processing projects and leading quality initiatives. Collaborating with multidisciplinary teams in a fast-paced biopharmaceutical environment.
Responsibilities
- Promotes a culture of safety
- Represents site MSAT on internal and external project teams as technical subject matter expert (SME)
- Interfaces with global MSAT, Manufacturing Operations and Quality functions
- Authors, reviews and approves GMP process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
- Leads complicated and multi-disciplinary change controls and will function as a lead for the project team
- Partner with Manufacturing to develop high-quality batch records, robust processes and innovative technology solutions
- Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation
- Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check
- Lead quality and technical risk assessment activities
- Support and/or lead technology transfer or new production introduction activities
- Provide training and technical knowledge sharing to manufacturing
- Partner with Validation and Quality groups in supporting equipment onboarding activities and periodic review programs as process owners
- Support and on-call rotating to support 24/7 operations
- Confident to act as a subject matter expert for regulatory and client inspection audits
- Apply Operational Excellence principles to lead continuous improvement ideas for manufacturing and technology transfer related activities
Requirements
- Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience
- Minimum of 2+ years of supporting upstream cell culture activities for biopharmaceutical products
- Knowledge and experience CMC stage gates for clinical and commercial biologics drug substance manufacturing programs
- Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology
- Solid understanding of upstream processing including hands on experience in single-use bioreactor operations and perfusion technology
- Solid understanding of GMP concepts and quality systems necessary to support manufacturing and new production introduction activities
- Working knowledge of manufacturing process equipment and automation systems
- Experienced deviation investigator and knowledgeable of root cause analysis tools (RCA)
- Possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
- Ability to organize, analyze/interpret, and effectively communicate process data
- Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders
- Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing.
Benefits
- Discretionary annual bonus
- Comprehensive benefits to include Medical, Dental and Vision
- Short-term and long-term disability
- Company paid basic life insurance
- 401k company match
- Flexible work
- Generous paid time off and paid holiday
- Wellness and transportation benefits
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