Process Engineer-Talent Bank

Process Engineer with experience in process validation .

The ideal candidate will be responsible for developing, validating, and improving manufacturing processes while ensuring compliance with relevant quality and regulatory standards.

This position plays a key role in supporting new product introductions, maintaining high product quality, and ensuring regulatory compliance in all aspects of process development.

Responsibilities : Lead and perform process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Develop and improve manufacturing processes using risk-based approaches and engineering best practices.

Prepare and maintain validation protocols, reports, and supporting documentation .

Drive continuous improvement initiatives using tools such as Design of Experiments (DOE), Root Cause Analysis (RCA), and Statistical Process Control (SPC).

Collaborate with cross-functional teams to support process development, troubleshooting, and optimization .

Create and update process documentation, including PFMEAs, process maps, and control plans .

Support audits by providing technical documentation and justification for process decisions.

Ensure compliance with applicable regulatory and quality standards (e.g., GMP, ISO 13485, FDA requirements).

Use statistical tools to analyze production data and improve process capability.

Qualifications : Bachelor’s degree in Engineering (e.g., Mechanical, Industrial, or related field).

• 3–7 years of experience in a regulated manufacturing environment , preferably in the medical device or similar industry .

Strong knowledge of process validation (IQ / OQ / PQ) and regulatory expectations.

Experience with risk management tools (such as FMEA) and validation planning.

Excellent technical writing and documentation skills.

Drug Free Workplace Policy : In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment." Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement.

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