Technical Operations Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Responsibilities:

• Support New Product Introduction (NPI) and existing products by actively participating in validation, qualification activities, and quality investigations.
• Author technical or validation protocols, reports, and other documentation related to existing products or NPI at the site.
• Provide exceptional technical support during NPI and ensure the successful manufacture of validation batches.
• Train the Manufacturing team to support manufacturing and process activities flawlessly.
• Demonstrate expertise in technical writing skills for reports, protocols, investigations, and change requests.
• Assist with day-to-day production tasks, including identifying problem causes, making process changes, and implementing new production technologies.
• Provide technical expertise for quality compliance activities such as documentation updates to batch records, SOPs, risk assessments, change control, investigations, and CAPA.
• Analyze and adjust process parameters, critical quality attributes (CQAs), and equipment performance using statistical tools during Continuous Process Verification (CPV) and Annual Product Review (APR).
• Participate in critical technical projects related to the production of commercial sterile pharmaceuticals.
• Attend project meetings to discuss customer production processes, approve production operation instructions, and resolve anomalies related to production standards.
• Promote and demonstrate EHS safe practices, ensuring all activities are conducted as per EHS standards and site safety SOPs. Participate in safety activities, HAZOPS, and process safety activities.

Education:

• Minimum requirement is a bachelor's degree in engineering, biological/chemical sciences, or related fields, or equivalent experience.

Experience:

• 2 to 4 years of pharmaceutical experience is preferred.

Knowledge, Skills, Abilities:

• Strong understanding of pharmaceutical manufacturing processes.
• Knowledge of GMP and Statistical Process Controls and related tools.
• Good computer skills and familiarity with laws and regulations relating to safety and environmental conservation.
• Flexibility, positive relationship skills, openness, and attentiveness.
• Specific experience in the production of sterile injectable drugs and packaging/visual inspection activities is preferred.
• Highly motivated to work in the pharmaceutical industry and able to work collaboratively as a team.