Senior Manufacturing Specialist, Qualification

This is what you will do:

The Manufacturing Specialist, Qualification is responsible for executing and sustaining qualification, certification, and compliance activities that ensure manufacturing assets, environments, and processes meet regulatory, safety, and performance standards. This role partners closely with Facilities, Quality, EHS, and Operations to drive risk-based decision making, maintain audit readiness, and implement continuous improvements across aging assets and controlled environments. This role will include participating in cross functional teams and multitasking several projects at one time.

You will be responsible for: 

• Qualification Authoring and Execution: Author and execute qualification protocols (IQ/OQ/PQ as applicable) for computerized systems, equipment, utilities, and environmental systems; ensure protocol compliance, data integrity, and real-time issue resolution.

• Investigations: Perform required investigations related to qualification and equipment, including root cause analysis, impact assessments, and documentation of deviations/nonconformances. Partner with Quality to define CAPA, verify effectiveness, and update qualification status or SOPs as needed.

• Audit/Inspection Technical Representation: Serve as a technical representative during internal audits and external regulatory inspections. Prepare evidence packages, respond to queries on qualification protocols/reports, environmental controls, and asset risk management, and drive timely CAPA closure for findings.

• Cross-Functional Facilities Support: Maintain cross-training in Facilities to provide operational support as needed, including equipment readiness checks, environmental monitoring support, and execution of minor qualification-related tasks during planned and unplanned events.

• Compliance and Documentation: Author, review, and maintain protocols, reports, SOPs, and work instructions aligned to applicable standards (e.g., cGMP, ISO, local regulations). Ensure data integrity, change control, training compliance, and controlled document management. Provide support for manufacturing change control development and execution.

• Continuous Improvement: Identify and implement process improvements in qualification lifecycle management, environmental control strategies, and asset reliability. Use metrics to monitor performance and drive corrective and preventive actions.

• Provide cross-functional support, as needed.

You will need to have:

• BA/BS degree is required

• Must be competent in Microsoft Word and Excel

• Must be able to use complex electronic systems such as SAP and Veeva Enterprise Quality Vault.

• Must have the capacity to develop in-depth knowledge of manufacturing operations and various quality systems

• Knowledge of cGMP, GEP, qualification/validation methodologies (IQ/OQ/PQ), and environmental controls.

• Experience with cleanroom/controlled environment standards.

• Familiarity with asset reliability, risk assessment techniques (e.g., FMEA), and CAPA management.

• Technical problem-solving skills

• Knowledge of current Good Manufacturing Practices (GMPs) and regulatory requirements

• Exceptional verbal and written communication skills

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.  Some qualification or other support work may need to be performed in off-hours.

We would prefer for you to have:

• Bachelor’s degree in engineering, life sciences, or a related field

• 4+ years of experience in a GMP biotech/ pharmaceutical manufacturing environment or have a significant level of transferrable work experience to ensure the immediate support of the manufacturing team, or 8+ years of directly related experience if there is no relevant BA/BS