Engineer at FIT Solutions providing innovative IT services and support. Collaborating with clients to troubleshoot and resolve technical issues as part of a hybrid work environment.
About the role
- Process Engineer III responsible for downstream processing in biopharmaceutical manufacturing at Just Evotec Biologic. Collaborating with teams to implement innovative solutions for process challenges.
Responsibilities
- Promotes a culture of safety
- Represents site MSAT on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT, Manufacturing Operations and Quality functions
- Possesses a deep understanding of downstream processes for the purification of biologics
- Authors, reviews and approves 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 Quality, Validation and Global MSAT to develop and implement process validation and comparability studies leading to successful product registration
- Is confident to act as a subject matter expert for regulatory and client inspection audits
- 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
- Facilitates new product introduction by leading make-a-batch sessions and supporting technical training for manufacturing
- Skilled at organizing data to optimize analysis and trending
- Experienced investigator and knowledgeable of root cause analysis tools (RCA)
- Support and on-call rotating to support 24/7 operations
- Apply Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing.
Requirements
- Masters (or Bachelors) degree in Engineering
- 4+ (7+) years of pharmaceutical/biotech experience including a minimum of 2+ years of supporting downstream purification 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 is required
- Technical purification and solution preparation operations using disposable-based manufacturing technologies
- 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
- Good interpersonal, team, and collaborative skills are required.
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
- paid holiday
- wellness and transportation benefits
Job title
Job type
Experience level
Salary
Degree requirement
No Education Requirement
Location requirements
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