MSAT Process Engineer - Drug Substance

Description

• Author and review change controls, including managing the implementation of changes as the assigned change agent.
• Collaborate with impacted groups to drive the implementation of CAPAs from approval to closure and effectiveness check.
• Author and review process-related documentation, including technical documents, test protocols, batch records, process descriptions, and SOPs.
• Support continuous improvement initiatives for upstream or downstream process improvements.

Requirements

• Good knowledge of Quality Management Systems and experience working with various manufacturing-related document types.
• Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology.
• Utilize technical skills and process knowledge to participate in or lead investigations related to process or new product implementation.
• Familiarity with root cause analysis methods and experience owning and authoring deviations.
• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
• Author and lead deviation investigations.
• Master's (or Bachelor's) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience.
• 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.
• Minimum of 2-4 years of experience supporting upstream cell culture or downstream purification manufacturing activities for biopharmaceutical products (downstream experience preferred).
• Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders.

Benefits

• Health Spending Account (HSA)
• Employee Assistance Program
• Transportation benefits
• Critical Illness, Accident, and Hospital
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Short and long-term disability
• Medical, dental & vision
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

Training + Development

Interview process

Visa Sponsorship

Security clearance