SUMMARY
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
QUALIFICATIONS
• Experience (manufacturing, process development, or quality assurance) in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems.
• Proficient and experienced in owning Change Controls.
• Project Management and/or Quality Management skills and experience. Demonstrated ability to coordinate and effectively participate in cross-functional project teams and deliver on schedule.
• Experience in leading multiple, contending priorities in a fast-paced environment with minimal direction.
• Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English, with ability to collaborate productively with technical and senior management staff.
• Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work and communicate effectively.
• Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
EDUCATION/EXPERIENCE
-Bachelors + 4 years of Manufacturing Operations experience
SUMMARY
Manages and/or applies extensive technical expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes. Employs an extensive technical knowledge of more than one area of engineering (process, unit operations, and equipment project) in complex process characterization, optimization, scale-up, or manufacturing support projects.
FUNCTIONS
EDUCATION/EXPERIENCE
-Bachelor's in mechanical or chemical engineering + 6 years of Engineering experience.
PREFERRED QUALIFICATIONS
o Experience Working with Clean Utilities Systems such as Distilled Water, Purified Water, RO System.
o Experience working on Clean Gases [Process Air, GMP gases supply like Oxygen, Nitrogen]
o Experience documenting and managing Deviation [non-conformance]
o Proficient in GMP documentation and the process improvement of SOP documents.
o Ability to work on Critical Operation and Capital project environment.
Job Description:
Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.
Currently, we are seeking for Commissioning & Qualification (C&Q) Consultant with experience within the regulated environment for the Manati, Puerto Rico.
Requirements:
Bachelor’s degree, with at least 5 years of relevant experience in CQV.Experience in Commissioning, Qualification, and Validation for New and/or existing equipment in areas of manufacturing.Knowledge of the Sterilization process, Valves, Pressure sensors, Control system (PLC/HMI) and Steam-in-place (SIP).Risk assessmentTechnical writing knowledgeOpen to work overtime and nonstandard hoursFully bilingual - Spanish & EnglishNote: This position does not offer visa sponsorship.
Work Location: In person
Company DescriptionPharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.Company DescriptionPharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide. Read LessPharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.
Currently, one of our clients in the Biotechnology sector is looking to hire a Project Engineer in Barceloneta, Puerto Rico.
Requirements:
Bachelor’s degree in engineering (mechanical, electrical)8-10 years of experience leading large capital projects in constructions.Program Management Professional (PMP) Certification, preferred.Significant construction experience in active, complex industrial facilities. Including safety elements.Demonstrated owner side or client facing experience in GMP regulated or pharmaceutical environments during construction activities.Proven track record working in a GC embedded role or closely integrated with general contractors on large capital projects.Develop project plans, including scope, planning, execution, control, and close-out activities, schedules, and budgets.Strong attention to detail and problem-solving skillsExcellent communication and leadership abilities in Spanish & English, requiredThis position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Please do not apply if you do not meet these requirements.
Company DescriptionPharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.Company DescriptionPharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for more than 30 years. Since our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide. Read Less