-
Biopharmaceutical SR. COMMISSIONING
1 week ago
MMR Consulting Raleigh, United StatesJob Description · Job DescriptionSalary: · Biopharmaceutical SENIOR COMMISSIONING & QUALIFICATION ENGINEER · Previous Pharmaceutical/Biotech experience is mandatory for this role. · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biote ...
-
Validation Lead
3 weeks ago
LAPORTE Raleigh, United StatesThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with client's global/si ...
-
Biopharmaceutical VALIDATION ENGINEER/SPECIALIST
3 weeks ago
MMR Consulting Inc Raleigh, United StatesPrevious 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 ...
-
Validation Lead
4 weeks ago
LAPORTE Raleigh, United StatesThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with clients global/sit ...
-
Validation Lead
4 weeks ago
LAPORTE Raleigh, United StatesThis position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with client's global/si ...
-
Validation Engineer
1 week 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 ...
-
Cleaning Validation Engineer
1 week 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 ...
-
Validation Engineer
2 weeks 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 ...
-
Pharmaceutical - VALIDATION ENGINEER
2 weeks 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 ...
-
Assoc. Director, Regional Marketing
3 weeks ago
TG Therapeutics Inc Raleigh, United StatesJOIN US · Open Position · Title: Associate Director, Regional Marketing · Location: Field · If you are interested in the below position, please send your resume to · and REFERENCE THE POSITION TITLE within the subject line. · Organizational Overview · TG Therapeutics is a fu ...
-
Validation Engineer
1 week 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 ...
-
Clean Utilities Engineer PQ LEAD
3 weeks ago
MMR Consulting Raleigh, United StatesJob Description · Job DescriptionSalary: · MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical, and biotechnology industries in the US and Canada. Its services include Engineering, Project Management, and other Consulting services. MMR's Engin ...
-
Pharmaceutical - VALIDATION ENGINEER
1 week ago
MMR Consulting Raleigh, United StatesJob Description · Job DescriptionSalary: · 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 industries in the ...
-
Director, Clinical Pharmacology
1 week ago
SpringWorks Therapeutics, Inc. Raleigh, United StatesAbout SpringWorks Therapeutics: · SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. · SpringWorks has a diversified targeted onco ...
-
Director, Clinical Pharmacology
4 days ago
SpringWorks Therapeutics Raleigh, United StatesAbout SpringWorks Therapeutics: · SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. · SpringWorks has a diversified targeted onco ...
-
Senior CQV Specialist
5 days ago
Wood PLC Raleigh, United StatesJOB DESCRIPTION · Wood PLC, on a global scale, serves the Pharma-Bio, Oil & Gas, Federal, Infrastructure, Manufacturing, Mining, and Power Industries. Our Philadelphia office has become the center of excellence for our global Life Sciences network. It provides process engineering ...
-
Senior CQV Project Manager
1 week ago
Jacobs Cary, United StatesWelcome. You haven't signed in yet so please select 'I accept' to start or access your Jacobs Career Application. · My Account Options · Senior CQV Project Manager (Life Sciences) · - · ( · LS-0004LK · ) · Your Impact: · Here at Jacobs, we apply our expertise and knowledge a ...
-
Jacobs Solutions Cary, United StatesYour Impact:Our People & Places Solutions business - reinforces our drive to improve the lives of people everywhere and epitomizes the "why" of what we do - the tremendous positive impact and value our solutions bring to our communities and society as a whole. From facilities del ...
-
Senior I&C Engineer
3 weeks ago
DPS Group LLC Cary, United StatesSummary · DPS is looking for a driven, team-oriented, Senior Instrumentation & Controls Engineer that specializes in the design, development, and specifying of Instrumentation & Controls equipment, components, or systems for life-science, biopharmaceutical, and/or microelectroni ...
-
Counsel I
1 week ago
Syneos Health, Inc Morrisville, United States· Counsel I · Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. · Every day we perform ...
Biopharmaceutical COMMISSIONING - 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 Bioprocess C&Q Engineer role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries.
The ideal candidate should possess leadership skills to lead/mentor intermediate/junior engineers.Responsibilities
Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and engineering specifications are met.
Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.
Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
Engage other departments, as required, for design reviews and decisions.
Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
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.
Visit construction and installation sites following all site safety requirements.Supervise contractors during critical testing of systems and equipment.
Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
Excellent written and spoken English is required including the preparation of technical documents in English
Years of experience:
Intermediate level: 4-6 yrs.
Senior level : 7-10+ yrs.
of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 4 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset, but not required.
Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is required
Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
Ability to lift 50 lbs.
Possess mentorship skills, to coach and develop junior and intermediate employees.
Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
Ability to handle multiple projects and work in a fast-paced environment.
Strong multi-tasking skills
Equal Employment Opportunity and Reasonable Accommodations
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
