Senior Process Development & Tech Engineer – GMP Biotech

Regeneron Pharmaceuticals, Inc.; Stati Uniti; In loco; USD 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonuses

Equity awards

401(k)

Health benefits

Paid time off

Family support

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking an experienced engineer to guide process development and scale-up for GMP assembly of combination products such as prefilled syringes and auto-injectors.

You will translate the QTPP into CQAs, develop risk-based plans for characterization, and establish CPPs while building a robust control strategy per ICH Q8-Q11 and Q9. You will plan end-to-end DoE-driven characterization, perform statistical analyses to define operating ranges, and collaborate on

Competenze

• BA/BS in Engineering field is required; 2+ years proven experience for Engineer level.
• Senior Engineer requires 5+ years proven experience in process development or related field.
• Experience with DoE, CPPs, CQAs, and QC processes within GMP environments.

Mansioni

• Guide process development and scale-up for GMP assembly of combination products.
• Translate QTPP into CQAs and build a control strategy using ICH Q8-Q11 and Q9.
• Plan DoE-based characterization and perform statistical analyses to define operating ranges.
• Collaborate on IPCs, sampling plans, PPQ approaches, and SPC with internal/external partners.
• Support tech transfer, regulatory filings, and change controls with detailed narratives.

Conoscenze

DoE

Statistical analysis

Cross-functional collaboration

GMP knowledge

Quality systems

Formazione

BS in Engineering

Strumenti

JMP

Minitab

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking an experienced engineer to guide process development and scale-up for GMP assembly of combination products such as prefilled syringes and auto-injectors.

You will translate the QTPP into CQAs, develop risk-based plans for characterization, and establish CPPs while building a robust control strategy per ICH Q8-Q11 and Q9. You will plan end-to-end DoE-driven characterization, perform statistical analyses to define operating ranges, and collaborate on