Process Engineer 3, Downstream–Site MSAT | Just.
– Redmond, WA and Seattle, WA |
Just-Evotec Biologics is seeking a highly motivated Downstream Process Engineer for site MSAT to join a fast-paced, collaborative, and multidisciplinary team.
The role report to Downstream Lead for site MSAT, and will be responsible to support all aspects of downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.
Roles and responsibilities:
Represents site MSAT on project teams as technical subject matter expert (SME) and interface with global MSAT, Operations and Quality functions.
Develop process understanding and expertise.
Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc)
Authors, reviews change controls including managing change implementation of the change as the assigned change agent.
Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability study activities leading to successful product registration.
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/ New product implementation.
Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
Monitors and reports on process performance data analysis
Ability to share 24/7 on call support activities during production.
Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.
Position Requirements:
Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience including a minimum of 2-4 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.
Excellent verbal and written communication skills in English; ability to interface with all levels of the organization
Additional Preferred Qualifications:
Experience in supporting audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff.
Experience in leading risk assessment and risk management for pharmaceutical products and processes.
Experience in applying principles of Quality by Design.
Entrepreneurial drive to achieve business objectives.
The base pay range for this position at commencement of employment is expected to be $111,360 to $159,000 ; Base salary offered may vary depending on individual’s skills, experience and competitive market value.
Additional total rewards include 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.
Evotec (US) Inc.
is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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