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QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

+ Provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.

+ Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.

+ Organizes, analyses and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

+ Provides solutions to a variety of technical problems of moderate scope and complexity.

+ Evaluate, select and apply standard engineering techniques and procedures.

+ Assistance given for unusual problems.

+ Perform assignments that have clear and specific objectives and require investigation of limited number of variables.

+ Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.

+ Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.

+ Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization.

+ Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.

+ Lead the implementation of equipment improvements projects.

+ SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.

+ Support equipment troubleshooting within the functional area or in the scope of technical expertise.

+ Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization.

Qualifications:

+ Bachelor’s degree in Engineering

+ 2 years of Engineering experience.

+ Experience in Biotech/Biopharma companies.

+ Experience in Deviations and implementing CAPAs.

+ Experience with CMMS system.

+ Proven experience working with operations, quality, and maintenance teams to deliver results in a fast-paced environment.

+ Understanding of cGMP, compliance, and documentation practices for regulated industries.

+ Comprehensive understanding of validation protocol execution requirements.

+ Ability to interpret and apply GLPs and GMPs

+ Basic technical presentations o Personal Organization o Validation Protocol Writing.

+ Strong communication, adaptability to change.

+ Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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