Manufacturing Process Engineer

Medasource; Concord (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Manufacturing Process Scientist in Concord, NC. The role involves supporting technical delivery and validation of parenteral operations, focusing on formulation, filling, and visual inspection. Candidates should have a Bachelor’s degree and 2+ years of experience in cGMP manufacturing, with strong skills in technical support and process validation. This position offers opportunities for mentorship and collaboration across teams.

Benefits

Medical insurance

Vision insurance

Qualifications

• 2+ years in cGMP manufacturing (validation, TSMS, QA, engineering, operations).
• Experience in pharmaceutical and/or medical device manufacturing preferred.

Responsibilities

• Support assigned parenteral process area as TSMS representative.
• Provide floor-level technical support during manufacturing operations.
• Lead non-routine investigations and provide quality/stability consultation.

Skills

Technical Support

Process Validation

Root Cause Investigation

Interpersonal Skills

Organizational Skills

Education

Bachelor’s degree in Engineering, Packaging Science, or related field

Tools

Microsoft Office

TrackWise

Electronic Batch Records

SAP

Job description

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Schedule: 12-hour shifts, 2-2-3, from 6AM-6PM or 6PM-6AM.

The Manufacturing Process Scientist is responsible for supporting the technical delivery and validation of parenteral operations, focusing on formulation, filling, or visual inspection (VI). This role supports technical transfer, process validation, and transition into commercial production while ensuring ongoing process capability and control. The scientist will serve as a technical leader within the TSMS team and provide expertise during both start-up and routine operations.

For senior and principal levels, additional responsibilities include mentoring junior team members and engaging with external stakeholders.

1. Support assigned parenteral process area (formulation, filling, or VI) as the TSMS representative.
2. Serve as the technical interface for manufacturing equipment, components, and operations.
3. Provide floor-level technical support during manufacturing operations and issue resolution.
4. Lead or support non-routine investigations (e.g., deviations, complaints) and provide quality/stability consultation.
5. Prepare, review, or approve technical documents such as:
6. Annual Product Reviews
7. Change Controls
8. Regulatory Submissions
9. Deviations
10. Validation Protocols/Reports
11. SOPs, PFDs, PFMEAs
12. Lead risk management and process improvement initiatives.
13. Develop and monitor real-time, statistically-based metrics for process control and capability.
14. Drive stability strategy and harmonize control strategies across teams.
15. Collaborate with upstream suppliers and the broader parenteral product network.
16. Provide audit support and represent the Concord TSMS team in internal and external communications.

Principal-level responsibilities also include mentoring TSMS team members and representing the Concord site in cross-site and upstream engagements.

Basic Qualifications

• Education: Bachelor’s degree or higher in Engineering, Packaging Science, or a related scientific field.
• Experience: 2+ years in cGMP manufacturing (validation, TSMS, QA, engineering, operations, etc.).

Preferred Skills & Experience

• Background in pharmaceutical and/or medical device manufacturing.
• Experience with root cause investigation methodologies.
• Proficiency with:
• Microsoft Office, TrackWise, Electronic Batch Records, SAP.
• Demonstrated success in leading cross-functional teams.
• Strong interpersonal, organizational, and self-management skills.

Seniority level

• Associate

Employment type

• Full-time

Job function

• Manufacturing and Science

Industries

• Hospitals and Health Care, Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance, Vision insurance.

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