About this role
Under minimal supervision, the Specialist Manufacturing supports the execution of manufacturing and quality systems including non‑conformances, process validation, procedures, training, and new product introductions. The role applies process, operational, and scientific expertise—along with compliance knowledge, analytical skills, and troubleshooting capabilities—to ensure robust, efficient, and compliant manufacturing operations. May serve as primary process owner for production support systems and assist with ownership responsibilities for more complex systems.
FUNCTIONS Initiate, revise, and approve manufacturing procedures; ensure alignment with current operations; serve as document owner. Assess process performance through floor observation and review of performance data; evaluate, plan, and implement process improvement opportunities. Provide troubleshooting support for manufacturing operations.
Assist in generating training materials and delivering training on scientific or technical aspects of the process. Ensure processes and procedures comply with cGMP and applicable regulations. Ensure risks are identified, assessed, and mitigated to protect product safety, purity, quality, and efficiency.
Ensure Electronic Batch Records (EBR) align with current processes and support training as needed. Assist and provide guidance during Master Batch Record (MBR) creation and revisions. Perform assessments to support process, automation, or equipment modifications and special projects.
Support establishment of process monitoring parameters and control limits. Collect and analyze process‑monitoring data; support deviation assessments. Support timely execution of quarterly process monitoring reports.
Participate in non‑commercial activity runs to support data collection and analysis. Ensure all non‑conformances are triaged within established timelines. Author investigation reports and execute corrective actions.
Manage NC/CAPA closure within established goals. Monitor and communicate incident trends. Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Complete assessments for CAPA applicability requests from other sites. Assist with generation and implementation of process validation protocols and reports. Support execution of process validation activities.
Collect and analyze validation data. Participate in regulatory inspections. Participate in New Product Introduction (NPI) activities, assessing documentation, materials, training, and equipment requirements.
Assess, prioritize, support, and provide project management for process or equipment modification projects. Support Risk Assessment exercises and microbial evaluation assessments. Provide commercial support and assist with on‑the‑floor troubleshooting when needed.
Own change controls and ensure implementation within established timelines. Assist manufacturing change owners with CCRB packages impacting the process. Complete assessments for new or modified Bills of Materials (BOMs).
Participate in the assessment and implementation of special projects or initiatives. Lead commercial campaign readiness and collaborate cross‑functionally to ensure alignment. SKILLS Detailed technical understanding of bioprocessing unit operations.
Skilled in GMP production operations. Regulatory knowledge and experience interacting with regulatory bodies. Ability to lead and participate in cross‑functional teams.
Strong communication and collaboration skills with technical and management staff. Strong organizational, technical writing, and presentation skills. Basic project management skills.
Knowledge of control charting and process monitoring. Proficiency in GDP (Good Documentation Practices). Ability to work independently and follow assignments through to completion.
Strong analytical skills for data trending and evaluation.
EDUCATION REQUIREMENTS Doctorate OR Master’s + 2 years of Manufacturing Operations experience OR Bachelor’s + 4 years of Manufacturing Operations experience OR Associate’s + 8 years of Manufacturing Operations experience OR High School/GED + 10 years of Manufacturing Operations experience. PREFERRED QUALIFICATIONS Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial) or Life Sciences. Experience in deviations management, deviation assessments, and TrackWise.
Knowledge in document handling using Veeva Vault (CDOCs) or similar platforms. Strong technical writing expertise. Experience owning change controls and managing project deliverables.
Experience with Smartsheet or similar project‑tracking platforms. Biotech or pharmaceutical manufacturing experience. Familiarity with Lean Manufacturing practices.
Experience supporting major/trend deviation investigations, including RCA, CAPA determination, and report authoring. Experience presenting investigations during regulatory inspections. Knowledge of systems such as TrackWise, Spotfire, CDOCS, and process monitoring platforms.
Strong communication skills in English and Spanish. Hands‑on experience in process engineering, manufacturing support, or production systems in regulated environments. Familiarity with automation systems, process equipment, and continuous improvement methodologies (Lean Six Sigma, Kaizen).
Administrative shift: 6-month contract with possible extension