Specialist Manufacturing

The Specialist Manufacturing supports the execution of manufacturing and quality systems with minimal supervision, 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 a primary process owner for production support systems and assist with ownership responsibilities for more complex process systems.

KEY RESPONSIBILITIES

• Initiate, revise, and approve manufacturing procedures; serve as document owner ensuring alignment with current operations.
• Assess process performance through floor observation and data review; identify, plan, and implement process improvement opportunities.
• Provide troubleshooting support for manufacturing operations.
• Develop and support delivery of technical/scientific training materials.
• Provide commercial support and assist with on‑the‑floor troubleshooting when required.
• Support establishment of process monitoring parameters and control limits.
• Collect, analyze, and interpret process‑monitoring data.
• Support timely execution of quarterly process monitoring reports.
• Complete assessments for CAPA applicability requests from other sites.
• Complete assessments for new or modified Bills of Materials (BOMs).
• Ensure non‑conformances are triaged within established timelines.
• Author investigation reports and determine root cause using structured methodologies (Fishbone, 5 Why’s, Six Boxes, Kepner‑Tregoe).
• Execute corrective and preventive actions.
• Manage NC/CAPA closure within defined goals.
• Monitor, analyze, and communicate incident trends.
• Review equipment/system RCA investigations and support trend evaluations.
• Support major/trend deviation investigations throughout their lifecycle.
• Assist in generating process validation protocols and reports.
• Support execution of validation activities.
• Collect, analyze, and interpret validation data.
• Design, coordinate, and support execution of functional tests, water runs, and other challenge tests during major changes or campaign readiness.
• Participate in regulatory inspections, new product introductions, and process/equipment modifications.
• Assess documentation, materials, training, and equipment requirements for NPI activities.
• Support microbial risk assessments and other compliance evaluations.
• Ensure adherence to GDP and regulated‑environment documentation standards.
• Own or support change controls for manufacturing process changes.
• Assist change owners with CCRB packages impacting manufacturing processes.
• Provide guidance during Master Batch Record (MBR) creation and revisions.
• Participate in assessments, implementation, and execution of special projects or continuous improvement initiatives.
• Support process, automation, or equipment modification projects.
• Serve as a peer‑recognized specialist in at least one technical area, determining methodologies and best practices.

CORE COMPETENCIES & SKILLS

• Detailed technical understanding of bioprocessing unit operations (cell culture, purification).
• Skilled in GMP production operations and regulated‑environment practices.
• Strong regulatory knowledge and experience supporting inspections.
• Ability to lead and collaborate across cross‑functional teams.
• Excellent organizational, technical writing, and presentation skills.
• Strong analytical, troubleshooting, and root‑cause analysis capabilities.
• Basic project management skills.
• Working knowledge of control charting and process monitoring tools.
• Ability to communicate effectively with manufacturing, process development, engineering, and quality teams.

EDUCATION REQUIREMENTS

One of the following is required:

• Doctorate, OR
• Master’s degree + 2 years of Manufacturing Operations experience, OR
• Bachelor’s degree + 4 years of Manufacturing Operations experience, OR
• Associate degree + 8 years of Manufacturing Operations experience, OR
• High school/GED + 10 years of Manufacturing Operations experience.

Preferred: Academic background in Engineering (Chemical, Mechanical, Industrial) or Life Sciences.

PREFERRED QUALIFICATIONS

• Hands‑on experience in manufacturing operations within biotech, pharmaceutical, or other regulated industries.
• Experience owning change controls and managing process changes.
• Strong deviation management experience, including authoring investigations and presenting during regulatory inspections.
• Experience supporting microbial risk assessments and contamination evaluations.
• Familiarity with Lean Manufacturing principles.
• Proficiency in GDP and regulated documentation standards.
• Technical writing expertise for investigations, protocols, and procedures.
• Experience with TrackWise, Spotfire, CDOCs/Veeva Vault, MES, and process monitoring platforms.
• Strong bilingual communication skills (English & Spanish).
• Demonstrated ability to lead campaign readiness activities and coordinate cross‑functional execution.
• Ability to design and execute functional tests, water runs, and process challenge studies.

• Contract position
• Shift Requirements
• Standard 8‑hour shift, Monday–Friday (8am–5pm).
• Flexibility for on‑call support as needed.