CQV / Validation Engineer
1 day ago
Position: CQV / Validation Lead
Job Description
We are currently expanding our team and are looking for a CQV / Validation Lead for our project on site with our client.
You will be responsible for overseeing, planning, writing, implementing and reviewing Validation protocols in place within highly regulated environments. Your expertise will lend a hand in tactical problem-solving, effective communication, and creating a progressive growth culture.
Key Responsibilities:
- Reporting to the C&Q Manager.
- Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard; re-enforce in meetings, perform periodic field observation and feedback as needed.
- Lead a team as the system owner in preparing and executing Biopharmaceutical Process Equipment C&Q documents, ensuring achievement of the project schedule, track and report progress to the C&Q Manager.
- Provide a strong working technical knowledge of Biopharmaceutical Process Equipment systems regarding the development of protocols, their execution, and close out.
- Provide technical oversight to a Biopharmaceutical Process Equipment C&Q team to assure technical work quality, consistency, and alignment with the C&Q programme.
- Work in the Kneat platform for preparation, review and approval of C&Q documentation with a key focus on traceability to User Requirements throughout.
- Coordinate with the Engineering Compliance team, the QA team and other stakeholders in assuring all decisions on the document preparation for Biopharmaceutical Process Equipment systems are aligned and agreed.
- Work collaboratively with the other project disciplines (e.g. automation, construction, engineering, end user) to support integration of activities.
- Train Biopharmaceutical Process Equipment personnel on the C&Q programme and it’s implementation in execution.
Requirements:
- Strong driver for timely execution and close out of C&Q protocols.
- Issues resolved in reasonable time before they impact critical path of Project.
- Issues identified, discussed, closed out and documented clearly.
- Proficient in the use of Kneat for C&Q document preparation and execution.
What’s in it for you?
- Exposure to the most renowned Pharmaceutical companies in the industry
- Annual leave benefits
- Full Medical coverage
- Training and Development allowance
If you are interested in applying for this position, please send an email to allison.aquino@cmcexpertisedelivered.com.
Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.
Tell employers what skills you have
DCS
Management Consulting
Construction
GMP
Root Cause Analysis
Traceability
Test Cases
Wireless
Writing
Life Sciences
Terminology
Electrical Engineering
Commissioning
-
Junior Project Manager
1 month ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timeRoles & ResponsibilitiesCommissioning / Qualification and Verification (CQV) Engineer (Singapore)PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering,...
-
Validation and Quality Expert
17 hours ago
Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full timeQuality Assurance Validator RoleAs a Quality Assurance Validator at MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD, you will partner with cross-functional teams to ensure quality oversight of commissioning, qualification, and validation lifecycle activities. This includes providing quality oversight to validation/qualification and continued verification of...
-
Singapore SURPASS STAFFING PTE. LTD. Full timeRoles & ResponsibilitiesResponsibilities: Execute commissioning, qualification, and validation (CQV) activities for mechanical equipment and systems utilized in Biopharma manufacturing facilities, adhering to regulatory standards and industry best practices. Create, assess, and implement validation protocols and reports for mechanical systems and...
-
QA Validation Expert
2 months ago
Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full timeRoles & ResponsibilitiesQA Validation Expert (Pharmaceutical/Commissioning/ Quality)Location: Gul CircleUp to $8,500 depending on experience12 Months ContractIndustry: PharmaceuticalJob Purpose Responsible to partner with cross-functional teams to provide quality oversight to commissioning, qualification, and validation (CQV) lifecycle activities ensuring...
-
Biopharmaceutical Validation Lead
17 hours ago
Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full timeCQV / Validation Lead Job DescriptionAs a CQV / Validation Lead, you will be responsible for overseeing, planning, writing, implementing, and reviewing validation protocols in highly regulated environments. Your technical expertise will contribute to tactical problem-solving, effective communication, and a progressive growth culture.Key...
-
QC Validation Specialist
2 months ago
Singapore NO DEVIATION PTE. LTD. Full timeRoles & ResponsibilitiesNo Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We...
-
Validation Engineer
5 months ago
Singapore MIKRON SINGAPORE PTE. LTD. Full timeRoles & ResponsibilitiesMain Responsibilities:1. Assist Quality and Validation Manager Asia to complete the tasks in time with good quality.2. Responsible for successful execution the Validation functions for customer project, as required – Quality, Cost, Time.3. Responsible to drive and support project team for projects where validation is required and...
-
Senior Engineer
1 day ago
Singapore NO DEVIATION PTE. LTD. Full timeRoles & ResponsibilitiesNo Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team.Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We...
-
Validation Engineer
1 day ago
Singapore NES GLOBAL PTE. LTD. Full timeRoles & ResponsibilitiesJob Title: Validation EngineerLocation: SingaporeStart Date: January 2025Duration: 1 year (Renewable contract)NES Fircroft has partnered with our client, a leading pharmaceutical company dedicated to innovation and quality in healthcare, to seek a Validation Engineer to join the team.POSITION RESPONSIBILITIES:-· Ensure equipment for...
-
Validation Engineer
1 day ago
Singapore T0SS-EX S PTE. LTD. Full timeRoles & ResponsibilitiesJob PurposeThe Commissioning & Validation Engineer provides specialized scientific and technical support for the validation, revalidation, and requalification of laboratory equipment and computerized systems. These activities are performed in strict adherence to current Good Manufacturing Practices (cGMPs), Standard Operating...
-
Validation Engineer
2 months ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timeRoles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...
-
Process Validation Engineer
2 days ago
Singapore Takeda Full timeAbout the Role:The Process Validation Engineer will be responsible for providing process validation support for Takeda vaccines manufacturing operations located in internal and CMO manufacturing locations. This includes overseeing process validation activities, developing and authoring process validation strategies, and ensuring compliance with cGMP...
-
Validation Engineer
1 day ago
Singapore RD TRUSTED PARTNERS PRIVATE LIMITED Full timeRoles & ResponsibilitiesJob Info: Monday to Friday 830 - 630 Location: Tai SengResponsibilities: Assist Quality and Validation Manager Asia to complete the tasks in time with good quality. Responsible for successful execution the Validation functions for customer project, as required – Quality, Cost, Time. Responsible to drive and support project team...
-
Validation Engineer
1 day ago
Singapore RECRUIT EXPERT PTE. LTD. Full timeRoles & Responsibilities Work closely with project team to assist Quality and Validation Manager Asia region to the tasks on schedule and within quality standard compliance. Responsible completion of the Quality, Cost, and Time validation functions for customer projects. Create and maintain qualification/validation documentation for mechanical, software,...
-
Computer System Validation Engineer
2 months ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timeRoles & ResponsibilitiesPharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world...
-
Validation Specialist
17 hours ago
Singapore RECRUIT EXPRESS PTE LTD Full timeJob SummaryA highly skilled Validation Specialist is needed to join our team at Recruit Express Pte Ltd. The successful candidate will be responsible for ensuring the validation and qualification of equipment, processes, and facilities in a cGMP manufacturing environment. This role requires a strong understanding of quality regulations and standards,...
-
Test and Validation Engineer
17 hours ago
Singapore UL VERIFICATION SERVICES PRIVATE LIMITED Full timeKey Responsibilities:As a key member of our team at UL Verification Services Private Limited, the Test and Validation Engineer will be responsible for leading and overseeing daily activities of assigned staff, providing performance feedback and staffing recommendations. The ideal candidate will have a strong background in Electrical Engineering and at least...
-
CSV Validation Specialist
17 hours ago
Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full timeJob Summary:As a CSV Validation Specialist at NUSANTARA PRIME CONSULTING PTE. LTD., you will be responsible for managing the Computer System Validation Lifecycle from design to execution phases. This includes creating and executing validation documents, protocols, and test cases using valgenesis software. You will work closely with Subject Matter Experts...
-
Sr. Verification and Validation Engineer
1 day ago
Singapore THALES SOLUTIONS ASIA PTE. LTD. Full timeRoles & ResponsibilitiesOrganisation ContextThe Airspace Mobility Solutions (AMS) business, part of the Global Business Unit Land and Air Systems, is providing leading edge Air Traffic Management (ATM), Unmanned Traffic Management (UTM), Security and Digital Aviation solutions for the Commercial and Defence sectors.The AMS business manages 11% of the...
-
CSV Validation Specialist
5 days ago
Singapore Amaris Consulting Full timeJob Title: CSV Validation SpecialistJob Summary:Amaris Consulting is seeking a skilled CSV Validation Specialist to join our team. The ideal candidate will have a strong background in computer systems validation within the pharmaceutical industry.Key Responsibilities:Develop and implement CSV strategy and validation plans for computerized systems.Create and...