Title: Specialist Manufacturing – 35601
Location: Juncos, Puerto Rico (Only for Puerto Rico Residents)
Schedule: Administrative Shift (Must be available to work overtime, alternate shifts, weekends, and holidays based on business needs.)
Contract Duration: 6 Months
Open Positions: 2
Position Summary
Our client is seeking a Specialist Manufacturing to support manufacturing operations and quality systems within a highly regulated biopharmaceutical manufacturing environment. This position is responsible for supporting manufacturing processes, quality systems, process validation, non-conformance investigations, CAPAs, Change Control activities, training, and New Product Introductions (NPI).
The selected candidate will apply technical knowledge, analytical thinking, scientific expertise, and problem-solving skills to improve manufacturing performance while ensuring compliance with cGMP regulations and company quality standards. This role may also serve as the process owner for assigned manufacturing support systems and contribute to continuous improvement initiatives.
Preferred Background
Bachelor's degree in one of the following disciplines is preferred:
- Chemical Engineering
- Mechanical Engineering
- Industrial Engineering
- Biotechnology
- Other Engineering or Life Sciences disciplines
Preferred Qualifications
The ideal candidate will have experience in one or more of the following areas:
- Manufacturing Operations or Process Engineering within the pharmaceutical, biotechnology, medical device, or other regulated industries.
- Manufacturing process support, production systems, or process optimization.
- Process validation, Change Control, CAPA, deviation investigations, and Root Cause Analysis.
- Manufacturing equipment, automation systems, and process technologies.
- Lean Manufacturing, Lean Six Sigma, Kaizen, or Continuous Improvement methodologies.
- Cross-functional collaboration with Manufacturing, Engineering, Quality, Validation, Maintenance, and Technical Operations teams.
- cGMP regulations, quality systems, compliance requirements, and Good Documentation Practices (GDP).
- Strong analytical, troubleshooting, organizational, and communication skills.
Key Responsibilities
Manufacturing Process Support
- Author, revise, review, and approve manufacturing procedures while ensuring documentation accurately reflects current manufacturing operations.
- Serve as the document owner for assigned manufacturing procedures and support documentation lifecycle activities.
- Monitor manufacturing operations through floor observations and performance data analysis.
- Identify process improvement opportunities and support implementation of effective solutions.
- Provide technical troubleshooting support to manufacturing operations.
- Assist in developing technical training materials and support training activities for manufacturing personnel.
Process Monitoring
- Support the establishment of process monitoring parameters and control limits.
- Collect, analyze, and interpret manufacturing process data.
- Assist in evaluating process deviations and identifying performance trends.
- Support the preparation and completion of quarterly process monitoring reports.
Non-Conformance (NC) & CAPA Management
- Ensure Non-Conformances (NCs) are triaged within established timelines.
- Author investigation reports for manufacturing events and deviations.
- Execute and track Corrective and Preventive Actions (CAPAs).
- Manage NC and CAPA activities through timely closure.
- Monitor, analyze, and communicate manufacturing and quality trends.
- Review Root Cause Analysis investigations related to manufacturing equipment and systems and support trend analysis.
Process Validation
- Assist in developing process validation protocols and reports.
- Support execution of process validation activities.
- Collect, analyze, and document validation data to ensure compliance with regulatory and quality requirements.
Regulatory Compliance & New Product Introduction (NPI)
- Support regulatory inspections, internal audits, and compliance initiatives.
- Participate in New Product Introduction (NPI) activities by evaluating documentation, training, materials, and equipment requirements.
- Support process and equipment modification projects by assisting with planning, implementation, prioritization, and project coordination.
Change Control
- Support Manufacturing Change Owners by preparing and coordinating Change Control Review Board (CCRB) documentation packages impacting manufacturing processes.
Projects & Continuous Improvement
- Participate in manufacturing improvement initiatives and special projects.
- Support operational excellence and continuous improvement efforts across manufacturing operations.
- Perform additional duties as assigned.
Minimum Education & Experience
Candidates must meet one of the following combinations:
- Doctorate degree
- Master's degree plus 2 years of Manufacturing Operations experience
- Bachelor's degree plus 4 years of Manufacturing Operations experience
- Associate degree plus 8 years of Manufacturing Operations experience
- High School Diploma or GED plus 10 years of Manufacturing Operations experience
Required Skills & Competencies
- Strong knowledge of bioprocessing and manufacturing operations.
- Experience working within FDA-regulated manufacturing environments.
- Knowledge of cGMP, Good Documentation Practices (GDP), and manufacturing compliance.
- Experience supporting process validation, Change Control, investigations, CAPAs, and Root Cause Analysis.
- Understanding of manufacturing process monitoring and continuous improvement methodologies.
- Ability to analyze manufacturing data and identify process improvement opportunities.
- Strong technical troubleshooting and problem-solving skills.
- Experience collaborating with Manufacturing, Engineering, Process Development, Validation, Technical Operations, and Quality teams.
- Excellent technical writing, documentation, and presentation skills.
- Strong verbal and written communication skills.
- Basic project management knowledge.
- Basic understanding of statistical process control and control charting.
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.