Senior manufacturing engineer - Katalyst CRO : Job Details

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Provides Quality Assurance (QA) support to Devens Site and reporting Manager through quality review and approval of investigations and corrective actions.

Decision-making of non-conformance through a deep understanding of quality systems and regulatory expectations.

Reviews and approves quality, quality control, validation, and automation-related documents.

Reviews and approves Standard Operating Procedures (SOPs).

Approves validation-related documentation such as risk assessments, protocols, test scripts, and summary reports.

Reviews and approves change proposals, ensuring compliance with external regulatory and internal guidelines.

Coaches across departments on investigations, CAPAs, risk assessments, and validation.

Self-manages and prioritizes work across multiple deliverables in a remote environment.

Interprets complex data and makes independent, sound decisions.

• Supports QA for investigations and corrective actions.
• Decides on non-conformance issues based on quality systems and regulations.
• Approves quality, validation, and automation documents.
• Approves SOPs and validation documents.
• Evaluates change proposals for compliance.
• Provides cross-department coaching on relevant topics.
• Manages multiple priorities remotely.
• Analyzes data for decision-making.

• B.S. in biological sciences, engineering, biochemistry, or related field preferred.
• At least 8 years of experience in GMP/GXP environments, with active membership in ASQ or ISPE preferred.
• Experience with QC equipment qualification and project management.
• Knowledge of biotech, drug manufacturing, or medical device testing desirable.
• Extensive knowledge of US/EU cGMP and GAMP 5.
• Experience with electronic systems like SAP, LIMS, TrackWise, Veeva Vault, or batch records.
• Strong technical writing and communication skills.
• Problem-solving skills and attention to detail.
• Experience working in FDA-regulated environments.
• Experience with QC equipment and investigations/deviations preferred.

Mid-Senior level

Contract

Pharmaceutical Manufacturing