Manufacturing Engineer

Location: Sanford/Morrisville, NC

Job Description:

We are seeking a highly skilled and experienced Process Development and Validation Specialist to join our team at our facility in Sanford/Morrisville, NC. The ideal candidate will have a proven track record in leading process qualification studies both at the bench and in a plant setting, with expertise in the development of manufacturing control strategies for synthesizing, purifying, identifying, and controlling impurities in API manufacturing.

Responsibilities:

• Lead and conduct process qualification studies in both laboratory and plant settings.
• Develop manufacturing control strategies, methods, and techniques for the synthesis, purification, identification, and control of impurities in API manufacturing.
• Implement process design, transfer, and validation activities for API manufacturing processes.
• Ensure compliance with current ICH, USP, FDA, EMA guidance, and standards related to process validation in API manufacturing.
• Collaborate with interdisciplinary project teams to understand project requirements, adhere to project timelines, and responsibly deliver commitments made to the project team.
• Complete all GMP and safety training in accordance with regulatory requirements.
• Utilize computer software and hardware applications, including Microsoft products, for documentation and communication purposes.

Requirements:

• Demonstrated experience in leading process qualification studies at both bench and plant levels.
• Proven expertise in the development of manufacturing control strategies for API manufacturing processes.
• Strong experience with process design, transfer, and validation for API manufacturing.
• In-depth knowledge and adherence to current ICH, USP, FDA, EMA guidance, and standards for process validation.
• Ability to work collaboratively in interdisciplinary project teams.
• Strong organizational and time-management skills to meet project timelines.
• Completion of all GMP and safety training in accordance with requirements.
• Proficiency in using computer software and hardware applications, including Microsoft products.

If you have a passion for driving excellence in process development and validation within the pharmaceutical industry and meet the above requirements, we invite you to apply for this exciting opportunity. Join us in our commitment to delivering high-quality products that positively impact global healthcare.

Job Type: Contract

Pay: $68,722.72 - $82,762.84 per year

Experience level:

• 3 years

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• North Carolina: Relocate before starting work (Required)

Work Location: In person