Bloomington, IN30+ days ago
Responsibilities: • Document (protocols, SOPs, summary reports) new processes and update existing processes where vital that will be reviewed by clients, corporate and regulatory auditors • Conduct development studies on critical equipment • Owns and onboards new client projects, including the relevant validations on syringe lines • Serve as line owner, conducting gap assessments and determining validation approaches when onboarding new projects • Collaborates directly with client representatives • Owns non-conformance investigations (NCR) • Owns corrective and preventive actions (CAPA) • Owns change control management tasks (CCM) • Participates in client audits and provides rationale / justification for practices with aid from senior team member / management • Responds to audit observations and owns deliverables • Subject matter expert for up to 3 processes, technologies or process equipment • Owns, plans interventions and leads syringe line media fills and has full ownership through closure of the summary • Owns & drives value improvement projects (VIP) to realize savings • Become trained and perform semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing). Required qualifications: • BS degree in science related field with laboratory experience or High School diploma/GED with a minimum of 6 years related experience within a pharmaceutical, biotechnology or related industry including responsibilities comparable to this position (e.g., technical writing, audit experience, project lead, authoring and performing studies, etc.) • Microsoft Office Suite (Word, Excel, Outlook) intermediate proficiency • Ability to use enterprise software (JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, etc.) • Critical thinking and problem-solving skills • High initiative and ability to deal with ambiguity • Skills to interact professionally and collaboratively with the client representatives • Good writing skills - including technical writing • Strong oral and written communication - including communication with external clients.