Senior Parenteral Inspection Technology Specialist
Flexible & Integrated Technical Services, LLC
For services Parenteral Inspection services.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor Degree in Sciences or Engineering ( Mechanical, Electrical or Computer) & five (5) years of exposure in the Pharmaceutical industry (Parenteral Manufacturing / Packaging Operations).
- Experience in:
- Strong background on Parenteral Inspection and Packaging processes is required with device assembly experience preferred.
- Understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes, specially packaging components for sterile products.
- Excellent technical writing/oral communication skills (English/Spanish).
The Personality Part:
- Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Improves inspection processes, technologies and systems to insure compliance with drug quality and cost specifications.
- Writes test procedures, inspection machinery specifications, performs line trials and trouble shooting, etc.
- Coordinates inspection process validation and line trial activities with local validation, production, engineering, planning and quality groups as needed.
- Supports new inspection technology and product transfers.
- Supports and assess current inspection processes; perform improvement or changes to existing inspection technology processes.
- Plans, coordinates, and executes projects to assure achievement of site’s departmental and company goals and objectives.
- Manage project timetables for new and on going projects.
- Provide project status through the use of project plans, presentations, or written reports.
- Provides troubleshooting inspection equipment, executing equipment trials and systems
- Provides assistance and technical support to inspection projects for products manufactured at the pharmaceutical manufacturing site.
BEING A FITS PIECE COMES WITH PERKS:
- One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!
WHO WE ARE:
We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!
Are you the Next Piece?
- Somos un patrono con igualdad de oportunidades en el empleo que mantiene la política de emplear y retener a los mejores candidatos independientemente de la raza, color, edad, religión, sexo, origen nacional, discapacidad física o mental, orientación sexual, identidad de...SeniorLunes a viernes
- ...reagent ordering, sample pickup and discarding, and execution of work orders. May represent the department during regulatory inspections (or internal and external audits). Provides input into the scheduling of assignments by the team lead/manager. Perform data...SugeridoContratoTrabajo por turnos
- ...We are seeking an experienced Validation / Commissioning Specialist to support a special project involving the replacement and qualification of load cells in a pharmaceutical manufacturing environment. Project Overview The selected candidate will support commissioning...SugeridoContrato
- ...of experience validating laboratory computerized systems in a manufacturing environment. Trained in validation methodologies, technologies, and process control computer systems. Strong knowledge of cGMP, FDA 21 CFR Part 11, and Data Integrity regulations....SugeridoTiempo completoTrabajar en la oficina
- Overview: Mentor Technical Group (MTG) provides specialized technical support and solutions for FDA-regulated industries. MTG is recognized for its expertise in life sciences engineering, ensuring compliance with pharmaceutical, biotechnology, and medical device safety...SugeridoTiempo completoTrabajar en la oficina
- ...manufacturing operations. Hands-on experience leading and supporting Technology Transfer projects, including project planning, team... ...Performs as Subject Matter Expert in liquid, lyophilized and syringe parenteral processes, and formulation, maintaining a current knowledge...Contrato
- ...general repair work on specific assigned working area/site of mechanical, electrical system and equipment. Perform effectively inspections, testing and emptying secondary containment systems (dams ) Correct deficiencies found in inspections. Report any spills...Tiempo completoInicio inmediatoTurno de nocheTrabajo por turnos
- ...the management of Production projects including the introduction of new projects and technology into Production, and Manufacturing Improvement. Works in concert with peers or senior staff in other departments to meet project timelines. Responsible for tracking the transfer...SeniorTemporalTurno rotativoTurno de noche
- ...compliance obligations with OSHA, CAL/OSHA, EPA, AQMD, ADA, and fire codes. ~ Serve as primary contact for all regulatory agencies for inspections, permitting, reporting (air, water, waste). ~Maintain compliance with permits, government regulations and other industry...Tiempo completoCAS
- ...ready to take on this new challenge? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Ensure EHS compliance through inspections, risk identification, and implementation of corrective actions. Manage the ergonomics program by conducting evaluations and...ContratoTrabajo por turnos
- Cost Control Services for Engineering and Capital Portfolios WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s degree in Finance, Engineering, or related field (advanced degree or PMP/CCP preferred). Five (5+) years of experience in capital project cost ...PrácticaContrato
- For Validation services WHAT MAKES YOU A FIT: The Technical Part: Bachelor's in Engineering with five (5) years of experience in Validation activities within the Medial Devices Industry. Bilingual: English and Spanish Soft Skills: Great attitude and strong...Trabajo por turnos
- ...We are seeking a C&Q Specialist responsible for executing and documenting Installation Qualification (IQ) and Operational Qualification (OQ) activities. Project Scope The C&Q activities will support a capital upgrade project that includes: Removal and...Contrato
- Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical...Tiempo completoTrabajar en la oficina
- ...of our leading clients in Puerto Rico. Position Overview We are seeking experienced Technical Writers / Manufacturing SOP Specialists to support a major initiative within a Biotech Drug Substance Manufacturing Operation in Barceloneta, Puerto Rico. The selected resources...Tiempo completo
- Support inventory analysis to define the scope of remediation across Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM) by leveraging automated tools and site-level expertise. This role will ensure...Contrato
- ...system ~Operational monitoring of the automation system in a parenteral plant ~ Monitoring, operation and repair of air compressors... ..., electrical system and equipment. ~Perform effectively inspections, testing and emptying secondary containment systems (dams) ~...Tiempo completoCASInicio inmediato
$17,5 - $21 por hora
...technicians enjoy all the tools and support – including the latest technology – to grow their careers and reach their goals. Walgreens is... ..., earns PTCB certification as condition of promotion to senior technician. Attends training requested by Manager and acquires...SeniorAprendizInicio inmediatoTurno de tarde- ...validation plans. Design and develop in‑process and receiving inspection systems for new components and processes. Generate... ...optimize, and improve manufacturing processes. Work with technologies such as laser welding, heat bonding, injection molding, vision...ContratoTrabajo por turnos
- ...private equity firm focused on investing in areas where information technology is enabling the disruption of industries by allowing a faster,... ...firm ABOUT YOU: You’ve been an assistant to a senior leader of a company, so you’re comfortable working in a dynamic...SeniorTiempo completoTrabajar en la oficinaRemotoTrabajo híbrido
- ...of accidents. # Investigate accidents to identify causes or to determine how such accidents might be prevented in the future. # Inspect or evaluate workplace environments, equipment, or practices to ensure compliance with safety standards and government regulations....Tiempo completoCAS
- ...system troubleshooting during and outside business hours as necessary. Responsible for the maintenance of assigned site operations technologies (OT) systems per applicable departmental procedures. Responsibilities Develop basic control configuration or programming...TemporalTiempo completoTurno de nocheFin de semana
- ...leader in the design, manufacture and distribution of world-class vision care products, including iconic eyewear, advanced lens technology and cutting-edge digital solutions. Join our global community of over 200,000 dedicated employees around the world in driving the...Salario mínimoTiempo completo
- ...responsibility which would enable the candidate to perform efficiently with a minimum of supervision. Exposure to FDA/DEA regulations and inspection. Excellent interpersonal relationships with direct reports, peers, and supervisors Must be fluent in Spanish and English,...TemporalTiempo completo
- ...deviations, discrepancies, and change controls related to C&Q activities are properly managed and resolved. Support regulatory inspections, audits, and internal quality reviews related to commissioned and qualified systems. Prepare and present regular status...ContratistaContratoTrabajo por turnos
- ...sterile packaging processes, including final packing and labeling, ensuring adherence to safety and quality standards. Conduct inspections of labeling systems and processes to guarantee accuracy and compliance. Collaborate with cross-functional teams to identify...ContratoTrabajo por turnos
- ...project. Ensure effective communication, alignment, and collaboration among all project stakeholders. Proactively keep site and senior management informed of risks, constraints, and conditions that may impact project scope, schedule, or cost. Prepare and present...SeniorContratistaPrácticaContratoTrabajo por turnos
- ...sterilization procedures. Perform process tests and participate in qualification and validation activities as required. Assemble and inspect equipment in the manufacturing area to confirm operational status. Work is performed in aseptic and non-aseptic environments....TemporalTiempo completoTrabajo por turnos
- ...Qualifications / Requirements / Knowledge / Skills: Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field . Proven experience in validation, qualification, and verification within a pharmaceutical manufacturing...Tiempo completoTrabajar en la oficina
$30 000 - $35 000 por año
...Black Dragon Capital LLC (BDC) is a unique growth-oriented private equity firm focused on investing in areas where information technology is enabling the disruption of industries by allowing a faster, better and more economically compelling way to solve industry issues...Tiempo completoContrato
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a Senior Parenteral Inspection Technology Specialist. ¡Sea el primero en aplicar!
