- Provide technical guidance into the commissioning, qualification and start-up of various pharmaceutical / biopharmaceutical cGMP process equipment, utilities & facilities.
- Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle
- Able to perform field execution of qualification test cases and protocols
- Support development of Project Validation Plans (PVPs) to ensure the action plan to test the system is applicable and relevant.
- Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
- Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following – Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
- Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
- Engage other departments, as required, into design reviews and decisions.
- Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
- Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification and validation phases.
- Visit construction and installation sites, wearing necessary safety PPE.
- You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
- Supervise contractors during critical testing of system and equipment.
- Other duties as assigned by client, and/or MMR, based on workload and project requirements.
- As this position requires working on client sites, you will need to comply with the client's safety rules including mandatory vaccination policies for COVID-19, where applicable
- Lead/Mentor a team of validation engineers/specialists.
- 12+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry.
- Experience with commissioning & qualification of equipment & facilities is required.
- Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
- Experience with developing and executing validation projects to Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ.
- Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered an asset.
- Experience with commissioning and qualification of biotech process equipment, such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF), CIP systems, Buffer systems, Clean Utilities would be an asset.
- Experience with Qualification or Validation of clean utilities and ISO clean rooms.
- Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
- Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues. Leadership is considered an asset, but not required.
- Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
- Possess mentorship skills, to coach and develop junior and intermediate employees.
- Engineering degree, preferably in Mechanical, Electrical or Chemical.
- Travel may be required on occasion.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills
-
Validation Specialist
2 weeks ago
Baanyan Software Services, Inc. Raleigh, United StatesA Bachelor's degree or higher in a relevant field. · Extensive experience in Cleaning Validation within the biotech and pharmaceutical sectors. · Strong hands-on experience with cleaning validation protocols and processes. · In-depth knowledge of industry regulations and best pra ...
-
Validation Specialist
2 weeks ago
Alliancebiotechsolutions Raleigh, United StatesAlliance Biotech Solutions (ABS) is a quality partner providing first in class solutions to the biotech and life sciences industries. While our offers are limitless, we are focused on providing Engineering, Qualification, and Compliance solutions for our clients. ABS employees ar ...
-
Validation Engineer
12 hours ago
Sequoia Biotech Consulting Raleigh, United StatesValidation Engineer · Position Overview: · We are looking for a talented and detail-oriented Validation Engineer to execute and oversee validation activities within our clients' pharmaceutical manufacturing facilities. The Validation Engineer will be responsible for planning, e ...
-
Validation Engineer
3 days ago
Barry-Wehmiller Companies Inc Raleigh, United StatesAbout Us: · Design Group operates from more than 45 offices in the United States and India, providing engineering, consulting and technical services for the world's leading companies in the food and beverage, life sciences, advanced technology, industrial and other market sector ...
-
Validation Engineers
1 week ago
Stellar Consulting Group LLC Raleigh, United StatesJob Description · Job Description · Validation Associates · is currently in search of · Validation Engineers · for our pharmaceutical clients nationwide, Multiple positions · All Visas Accepted- · OPT/CPT/GC/USC/TN/L2 - · Multiple Positions- Nationwide. · (US Candidates o ...
-
Validation Engineer
1 week ago
Valspec Raleigh, United StatesJob Description · Job Description · Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spec ...
-
Validation Engineer
2 weeks ago
Hugheseng Raleigh, United StatesHughes Engineering & Consulting · is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career development as well ...
-
Validation Engineer
2 weeks ago
Hughes Engineering, PLLC Raleigh, United StatesHughes Engineering & Consulting · is an exciting, fast-growing company focused on Process Engineering, Project Engineering, Project Management and CQV solutions for the pharmaceutical industry. We offer great benefits, and exciting challenges for both career development as well ...
-
Validation Engineer
4 days ago
Valspec Raleigh, United StatesJob Description · Job DescriptionValspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec's mission is to provide a wide spectrum ...
-
Validation Engineer
12 hours ago
Valspec Raleigh, United StatesValidation Engineer (MES) · Location: Durham, North Carolina · Provide computer system validation support for a leading contract development and manufacturing organization (CDMO) specializing in the production of biologics and advanced therapies. We are seeking a flexible and a ...
-
Validation Engineer
1 week ago
Precision for Medicine Raleigh, United StatesValidation Engineer · at Precision Medicine Group (View all jobs) · Raleigh, North Carolina, United States · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments We are thrilled to present an incredible opportunity to join our ...
-
Cleaning validation specialist
3 weeks ago
Solios Corp Raleigh, United StatesJob Title: Cleaning Validation Specialist · Location: Worcester MA(or) Raleigh NC · Duration: 6+ months with possible extension · Position Overview: · Need highly qualified candidates for the role of Cleaning Validation Specialist. The ideal candidate should possess a substan ...
-
Cleaning Validation Specialist
2 weeks ago
IT Resource Hunter Raleigh, United StatesPosition Overview: · Need highly qualified candidates for the role of Cleaning Validation Specialist. The ideal candidate should possess a substantial background in Cleaning Validation within the biotech and pharmaceutical industries, with a strong emphasis on hands-on experience ...
-
Cleaning Validation Engineer
12 hours ago
HYDE ENGINEERING + CONSULTING Raleigh, United StatesThe Cleaning Validation Engineer is responsible for cleaning and process engineering and validation in the biotech and pharmaceutical industries. This individual will generate, execute, and report on testing for multiple phases of commissioning and qualification. · The position i ...
-
Process Validation Engineer
1 week ago
Technical Source Raleigh, United StatesTechnical Source is currently in search of a · Process Validation Engineer · for our pharmaceutical manufacturing client in the Rocky Mount-Wilson, NC area. This is a long-term contract opportunity that operates on a rotating shift schedule. The ideal candidate for this positio ...
-
Process Validation Engineer
2 weeks ago
Piper Companies Raleigh, United StatesPiper Life Sciences is actively seeking a Process Validation Engineer to join a global pharmaceuticalcompany that addresses unmet medical needs of people living with and chronic and ongoing disorders. This position will work traditional hours, Monday - Friday, in the greater Rale ...
-
Cleaning Validation Engineer
5 days ago
Mastech Digital Raleigh, United StatesRole: Cleaning Validation EngineerRaleigh, NCContract role. · Do you have the skills to fill this role Read the complete details below, and make your application today. · Job Description:Looking for a Cleaning Validation Engineer.Heavy background in Cleaning Validation in the b ...
-
Pharmaceutical - VALIDATION ENGINEER
1 week ago
MMR Consulting Inc Raleigh, United StatesJob Description · Job Description Salary: · Pharmaceutical - VALIDATION ENGINEER · Previous · Pharmaceutical/Biotech · experience is mandatory for this role · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industrie ...
-
Cleaning Validation Engineer
1 week ago
Mastech Digital Raleigh, United StatesRole: Cleaning Validation Engineer · Raleigh, NC · Contract role. · Do you have the skills to fill this role Read the complete details below, and make your application today. · Job Description: · Looking for a Cleaning Validation Engineer. · Heavy background in Cleaning Val ...
-
Senior Validation Engineer
1 week ago
Precision for Medicine Raleigh, United StatesSenior Validation Engineer · at Precision Medicine Group (View all jobs) · Raleigh, North Carolina, United States · Why Precision for Medicine? · Welcome to the forefront of innovation in cutting edge patient treatments We are thrilled to present an incredible opportunity to jo ...
Biopharmaceutical VALIDATION ENGINEER/SPECIALIST - Raleigh, United States - MMR Consulting Inc
Description
Previous Pharmaceutical/Biotech experience is mandatory for this role.MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and other Consulting services. MMR's Engineering expertise includes Process, Automation, Facilities engineering.
Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers and specialists involved in project management, commissioning and qualification, of equipment, systems and facilities.
The work will require working out of the client's facilities.This role is for
Sr. Validation Specialist
role to work on the validation of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.
Responsibilities
MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.
#J-18808-Ljbffr