Specialist Manufacturing

With minimal supervision, the Specialist Manufacturing supports the execution of key 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 and compliant manufacturing operations. The Specialist may serve as a primary process owner for designated production support systems and contribute to process ownership responsibilities for more complex systems.

FUNCTIONS

• Initiate, revise, and approve manufacturing procedures; serve as document owner ensuring procedures reflect current operations.
• Assess process performance through floor observation and data review; identify, plan, and implement process improvement opportunities.
• Provide troubleshooting support for manufacturing operations.
• Assist in generating training materials and deliver training on scientific or technical aspects of the process.
• Provide commercial support and floor troubleshooting during campaigns as needed.
• Support establishment of process monitoring parameters and control limits.
• Collect and analyze process‑monitoring data; support deviation assessments.
• Contribute to timely execution of quarterly process monitoring reports.
• Ensure timely triage of non‑conformances within established goals.
• Author investigation reports and execute corrective actions.
• Manage NC/CAPA closure within required timelines.
• Monitor, communicate, and evaluate incident trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.
• Complete CAPA applicability assessments from other sites.
• Assist in generating validation protocols and reports.
• Support execution of process validation activities.
• Collect, analyze, and interpret validation data.
• Participate in regulatory inspections, New Product Introductions (NPI), and process/equipment modifications.
• Assess documentation, materials, training, and equipment requirements for NPIs.
• Provide project management support for process or equipment modification initiatives.
• Support risk assessments and microbial evaluation exercises.
• Assist manufacturing change owners with CCRB packages impacting the process.
• Own change controls for manufacturing process changes.
• Support Master Batch Record (MBR) creation and revisions.
• Complete assessments for new or modified Bills of Materials (BOMs).
• Participate in special projects, automation improvements, and equipment modification assessments.
• Design, coordinate, and support execution of functional tests, water tests, and other challenge runs during major changes or campaign readiness.
• Serve as a peer‑recognized specialist in at least one technical area, determining methodologies and best practices.

COMPETENCIES & SKILLS

• Detailed technical understanding of bioprocessing unit operations (Cell Culture, Drug Substance Purification).
• Skilled in GMP production operations.
• Strong regulatory knowledge and experience interacting with regulatory bodies.
• Ability to lead and participate in cross‑functional teams.
• Strong communication and collaboration skills with manufacturing, process development, and quality teams.
• Excellent organizational, technical writing, and presentation abilities.
• Basic project management skills.
• Knowledge of control charting and process monitoring methodologies.
• Proficiency in GDP (Good Documentation Practices).
• Strong troubleshooting and analytical skills.

TECHNICAL SYSTEMS EXPERIENCE

• TrackWise
• VEEVA
• MES
• Spotfire
• CDOCS
• SmartSheet
• Power BI
• Process monitoring platforms
• ChatGPT / Copilot (for documentation and analysis support)

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

• Educational background in Life Sciences or Engineering.
• In‑depth experience with bioprocessing unit operations.
• Expertise in Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why’s, Kepner‑Tregoe).
• Familiarity with Lean Manufacturing practices.
• Strong bilingual communication skills (English & Spanish).
• Excellent interpersonal skills and teamwork orientation.
• Ability to work under minimal supervision, high workload, and pressure.
• Availability for extended hours, on‑call support, and overtime based on business needs.
• Experience in deviations management, deviation assessments, and biotech manufacturing environments.

SHIFT

• Standard: Monday–Friday, 8am–5pm
• Flexibility for overtime, extended hours.
• 1 year contract