Senior Manufacturing Specialist

AstraZeneca•Bogart, GA

About The Position

The Senior Manufacturing Specialist is responsible for sustaining asset management programs and facilities program compliance to ensure manufacturing readiness, safety, and regulatory conformance. This role partners closely with Facilities, Quality, EHS, Operations, and external service providers to drive risk-based decisions, maintain audit readiness, and implement continuous improvements across equipment lifecycle and facility programs. You will be responsible for: Pest Control Program Oversight: Manage the site pest control program, including alignment of trap/map locations to vendor reports, routine audits, and joint walkthroughs with the vendor at each service visit. Maintain documentation, trend findings, and drive corrective actions. Equipment Lifecycle Oversight: Lead the decommissioning process and the equipment tagging/return-to-service program, ensuring risk assessments, verification checks, documentation, and approvals are completed prior to asset disposition or restart. Own the archive of equipment folders for assets decommissioned more than two years ago; ensure complete records, traceability, and compliant storage/access in accordance with document control requirements. Author and publish quarterly equipment change memoranda summarizing modifications, replacements, and configuration updates; ensure distribution, archive, and linkage to change controls and impacted SOPs/forms. Maintain cross-training in qualification/validation to support protocol/report review and act as backup for qualification activities as needed. Work Order Process Oversight: Lead improvements to Work Order (WO) processes and Equipment SOPs, including standardized forms, data fields, and tracking workflows for initiation, execution, and closure. Coordinate cross-functional reviews and training updates. Execute routine audits of work orders to verify completion status, documentation quality, and alignment to governing SOPs; issue findings, actions, and track CAPA effectiveness. Technical representative for audits/inspections: Serve as facilities technical rep during internal audits and external regulatory inspections; prepare evidence packages, respond to queries on facility programs, WO controls, equipment lifecycle, and pest control oversight; support timely CAPA closure. Compliance and documentation: Author, review, and maintain SOPs, work instructions, logs, maps, and memos aligned to applicable standards (e.g., cGMP, GEP, IACUC, local regulations). Ensure data integrity, change control, training compliance, and controlled document management. Investigations and CAPA: Perform investigations related to facility/equipment issues; conduct root cause analysis and impact assessments; partner with Quality to define CAPA, verify effectiveness, and update SOPs or program controls. Provide cross-functional support, including project management, as needed.

Requirements

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 understanding of manufacturing operations, facilities/maintenance programs, and equipment lifecycle management.
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.

Nice To Haves

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

Responsibilities

Manage the site pest control program, including alignment of trap/map locations to vendor reports, routine audits, and joint walkthroughs with the vendor at each service visit. Maintain documentation, trend findings, and drive corrective actions.
Lead the decommissioning process and the equipment tagging/return-to-service program, ensuring risk assessments, verification checks, documentation, and approvals are completed prior to asset disposition or restart.
Own the archive of equipment folders for assets decommissioned more than two years ago; ensure complete records, traceability, and compliant storage/access in accordance with document control requirements.
Author and publish quarterly equipment change memoranda summarizing modifications, replacements, and configuration updates; ensure distribution, archive, and linkage to change controls and impacted SOPs/forms.
Maintain cross-training in qualification/validation to support protocol/report review and act as backup for qualification activities as needed.
Lead improvements to Work Order (WO) processes and Equipment SOPs, including standardized forms, data fields, and tracking workflows for initiation, execution, and closure. Coordinate cross-functional reviews and training updates.
Execute routine audits of work orders to verify completion status, documentation quality, and alignment to governing SOPs; issue findings, actions, and track CAPA effectiveness.
Serve as facilities technical rep during internal audits and external regulatory inspections; prepare evidence packages, respond to queries on facility programs, WO controls, equipment lifecycle, and pest control oversight; support timely CAPA closure.
Author, review, and maintain SOPs, work instructions, logs, maps, and memos aligned to applicable standards (e.g., cGMP, GEP, IACUC, local regulations). Ensure data integrity, change control, training compliance, and controlled document management.
Perform investigations related to facility/equipment issues; conduct root cause analysis and impact assessments; partner with Quality to define CAPA, verify effectiveness, and update SOPs or program controls.
Provide cross-functional support, including project management, as needed.