Manufacturing Technical Operations Specialist

Location: Durham, NC

Job Type: Contract – 12+ Months

We are seeking an experienced Manufacturing Technical Operations Specialist to support pharmaceutical/biopharmaceutical manufacturing operations in Durham, NC.

This position is ideal for a manufacturing professional with 3–5 years of experience who has strong hands-on knowledge of manufacturing equipment, technical documentation, protocol authoring, deviation investigations, and process validation.

Key Responsibilities

Develop, review, and maintain manufacturing documentation, including SOPs, protocols, batch records, work instructions, and technical reports.

Author and execute protocols supporting process validation and manufacturing operations.

Support and lead deviation investigations, including root cause analysis and corrective/preventive actions.

Maintain accurate and compliant manufacturing records and documentation.

Utilize SIM (Site Information Management) or related manufacturing information systems to manage operational data and documentation.

Support process validation activities and ensure processes and equipment meet established requirements.

Work closely with Manufacturing, Quality, Validation, and Engineering teams to troubleshoot operational and equipment-related issues.

Provide technical support for manufacturing equipment and processes.

Identify opportunities for process improvements and support implementation.

Ensure all activities comply with cGMP, SOPs, quality systems, and applicable regulatory requirements.

Required Qualifications

3–5 years of experience in pharmaceutical, biotechnology, life sciences, or other regulated manufacturing environments.

Strong experience with technical writing and manufacturing documentation.

Hands-on experience with protocol authoring and execution.

Experience conducting or supporting deviation investigations and root cause analysis.

Knowledge of manufacturing equipment and manufacturing processes.

Experience with process validation.

Familiarity with SIM or similar manufacturing information/documentation systems.

Working knowledge of cGMP requirements.

Strong organizational, documentation, communication, and problem-solving skills.

Preferred Qualifications

Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related discipline.

Experience working in a GMP pharmaceutical or biopharmaceutical manufacturing facility.

Experience collaborating with Quality, Engineering, Validation, and Manufacturing teams.

Experience supporting equipment-related investigations, qualification, or validation activities.

What We're Looking For

The strongest candidates will combine excellent documentation skills with practical manufacturing equipment knowledge. Candidates should be comfortable working in a regulated manufacturing environment where documentation accuracy, investigation quality, and GMP compliance are critical.

Apply today for immediate consideration. Interviews are expected to begin quickly for a targeted mid-September start.

Arthur Lawrence is a US-focused management consulting and staffing firm placing talent across IT, finance, light industries, and pharmaceuticals. We work with Fortune 500 clients and operate with a delivery-first mindset backed by a strong internal training culture.