C&Q Specialist
Mentor Technical Group
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, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
- Collaborate with C&Q Engineers to develop and maintain commissioning and qualification procedures and documents.
- Write, review, and approve C&Q protocols and reports for various systems (e.g., HVAC, utilities, production equipment, lab equipment).
- Execute commissioning and qualification activities for plants and equipment.
- Coordinate with external consultants and internal resources to ensure timely document generation and execution.
- Manage change controls and deviations related to plants and equipment.
- Support maintenance and calibration functions to improve compliance and quality.
- Provide expertise in troubleshooting and root cause investigations.
- Facilitate the transfer of technical knowledge across units and sites.
Qualifications Requirements/Knowledge/Education/Skills:
- Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Technology, or a related scientific field.
- At least 2 years of experience in GMP manufacturing relevant to the area of expertise.
- Proficiency in English; additional language skills are a plus.
- Strong understanding of regulatory requirements and quality standards.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work collaboratively in a team environment.
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group 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.
- ...For C&Q services in the Business Operations area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Science, or Engineering field with at least 2 years of proven experience in commissioning and qualification processes, protocol generation and...SugeridoContratoTrabajo por turnos
- For C&Q services in Capital Projects area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Science or Engineering with five (5) years of experience in the validation life cycle, within the pharmaceutical industry. Bilingual (English & Spanish...SugeridoContratoTrabajo por turnos
- 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...SugeridoContratoTrabajo por turnos
- • Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. • Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions...SugeridoContratoTrabajo por turnos
- For QA Services in the Drug Substance a rea. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with four (4) years of experience within the pharmaceutical or regulated industry. Bilingual (English & Spanish). Project Management skills. ...SugeridoContratoTrabajo por turnos
- ...requests from other plants/sites Complete assessment for new or changes in BOM's (Bill of Materials) Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area. Qualifications: Bachelor's...ContratoTrabajo por turnos
- Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico . Administrative Shift Shift: (M-F | 8am to 5pm | OT may be requested...Trabajo por turnos
- ...website qrcgroup.com / to learn more about our services and solutions! Job Description We are seeking a Quality Assurance Specialist to perform critical QA oversight activities, ensuring compliance with regulatory requirements, internal quality standards, and...Contrato
- Inteldot has over 15 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico . Administrative Shift Shift: (8hrs shift | Availability to work...Trabajo por turnos
- For Manufacturing Services in the Quality Systems a rea. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with five (5) years of experience as a Scientist within the pharmaceutical or regulated industry. Bilingual (English & Spanish). Project...ContratoTrabajo por turnos
- For Quality services in the Manufacturing/Engineering area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree in Engineering or Life Sciences and at least five (5) years of experience in Quality activities within the medical device industry. Bilingual...ContratoTrabajo por turnos
- ...We are seeking a Specialist QA. The responsibilities include: • Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR,...ContratistaContrato
- We are seeking Quality Professional with experienced working in biopharmaceutical industry, quality organization supporting deviations, validation reports, qualifications, investigations, at least 5 years of experienced in a highly regulated environment . Requirements...Contrato
- Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico. Administrative Shift Job Description: Under minimal ...Tiempo completoTrabajo por turnos
- The candidate should poses a BS in Science, Engineering, Physics, Biology, Chemistry or related fields. It should have experienced working in the pharmaceutical industry, quality organization supporting deviations, validation reports, qualifications, investigations...Contrato
- 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...ContratoLunes a viernes
- Bachelor's degree in engineering is a plus Deviations management Deviation assessments Track wise Biotech and manufacturing experience Requirements Doctorate OR Master’s + 2 years of Manufacturing Operations experience Alternatively, Bachelors + 4...ContratoTrabajo por turnos
- Engineering Experience in Manufacturing Operations – Hands-on experience in process engineering, manufacturing support, or production systems within a regulated environment (biotech, pharmaceutical, or similar). Technical Knowledge – Familiarity with automation systems...Contrato
- ...requests from other plants/sites Complete assessment for new or changes in BOM's (Bill of Materials) Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area. Qualifications: Bachelor's...Contrato
- For Maintenance services. WHAT MAKES YOU A FIT: The Technical Part: Bachelor's degree in Engineering with (3) years within the Pharmaceutical or Medical Device Industry. Shift: Administrative and according to business needs. Good communications skills...ContratoTrabajo por turnos
- For Health and Safety support WHAT MAKES YOU A FIT: The Technical Part: ~ Bachelor’s Degree and or an equivalent of five (5) years of exposure in Industrial and Constructions projects within the regulated industry. ~ Bilingual (Spanish and English). ~ Good ...ContratistaSubcontratistaContratoTrabajo por turnosLunes a viernes
- o Knowledge in document handling on Veeva Vault (CDOCs) or similar platforms o Technical writing expertise o Change control handling (owner) o Project handling o Use of Smartsheet or similar platform Requirements Doctorate OR Master’s + 2 years...ContratoTrabajo por turnos
- Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ, PQ, Functional Test). In addition to Technical Writing, Quality Systems (Deviations, Change Control) and Maintenance (...Contrato
- Experience of bio-processing unit operations Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe) Familiar with Lean Manufacturing Practices Ability to communicate and collaborate with technical and management...ContratoTrabajo por turnos
- ...the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)). Minimum of 4 years of relevant... ...approaches to solutions. Coaches and reviews the work of lower-level specialists; may manage projects and processes. May be responsible for...ContratoTrabajo híbridoTrabajo por turnos
- ...of discipline expertise to broad variety of assignments in related fields. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area. Application of mature engineering...ContratoTrabajo por turnos
- ...of discipline expertise to broad variety of assignments in related fields. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area. Qualifications: Bachelor’s degree...ContratoTrabajo por turnos
- ...discipline expertise to a wide variety of assignments in related fields. Serves as a peer-recognized engineering technology specialist in at least one area, responsible for determining methodologies in that area. Application of mature engineering knowledge in planning...ContratoTurno de nocheTrabajo por turnos
- ...of discipline expertise to broad variety of assignments in related fields. ~ Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area. ~ Application of mature...Tiempo completoTrabajo por turnos
- ...of discipline expertise to broad variety of assignments in related fields. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area. Qualifications: ~ Bachelor’s degree...Turno de mañana
¿Desea recibir más vacantes?
Suscríbase y reciba vacantes similares a C&Q Specialist. ¡Sea el primero en aplicar!
