Bakemark Canada Jobs in Usa
987 positions found — Page 46
Job Functions:
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Author, revise, review and approve site procedures and policies related to Environmental Monitoring and Sterility as applicable.
- Author quality control EM data trend charts and reports.
- Serve as backup in the absence of microbiology supervisor/management
- Employ aseptic techniques in the performance of testing per USP and Curium Standard Operating Procedures (SOP) and Standard Test Methods (STM) for Sterility, Endotoxin, Bioburden on drug products, intermediates and raw materials.
- Train new employees in microbiological and aseptic techniques and serve as mentor for new and junior employees.
- Perform Growth Promotion testing, Bioburden, and/or sterility testing
- Prepare and analyze Biological Indicators in support of various Validation and Qualification activities.
- Read plates to quantify microbial growth and subculture pure isolates as required.
- General laboratory housekeeping duties.
- Assist with laboratory investigations including OOS, root cause analysis, and implementation of corrective and preventative actions.
- Ensure a safe and quality-minded working environment through conformance with training, general awareness, and compliance to safety/Quality guidelines and SOPs.
Education and Experience:
- Bachelor Degree required (Microbiology, Biology, Cellualar Bigology preferred).
- Five or more years of relevant experience required.
- Previous experience with aseptic process simulations preferred.
- Quality and production experience in a cGMP / FDA regulated facility is required.
#IND-SPG
Estimated Min Rate: $80000.00
Estimated Max Rate: $94000.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
Title: Raw Material Inspector
Location: Bristol, PA
Schedule: M-F 8-5pm with some occasional weekend work
Duration: 3- 6 months with possibility to go longer
Pay: $25-$40/hr DOE
Essential Duties and Responsibilities
- Perform physical, visual, and analytical inspection/sampling of incoming raw materials and packaging components in accordance with Standard Operating Procedures (SOPs) and sampling plans.
- Maintain detailed, accurate records of inspections following Good Documentation Practices (GDP) and cGMP regulations.
- Label and manage the status of materials in the warehouse, including Quarantine, Released, or Rejected.
- Utilize laboratory equipment (e.g., balances, pH meters, moisture analyzers, infrared spectrometers, endotoxin) to verify identity and purity.
- Identify, document, and report non-conforming materials to QA and Procurement. Initiate deviations or material rejection reports when necessary.
- Review Certificates of Analysis (CoAs) for accuracy and completeness.
- Ensure the sampling area and equipment are properly maintained, calibrated, and cleaned.
- Author, review and approve SOPs, protocols, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards.
- Release of raw materials
- COSMOS
- BS/BA degree in a relevant life sciences discipline or equivalent.
- Minimum of 3 years in a GMP oriented environment and raw materials testing
- Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
#IND-SPG
Estimated Min Rate: $21.00
Estimated Max Rate: $30.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
Title: QA Doc Control Contractor
Pay: $25-$30/hr DOE
Duration: 3- 6 months with possibility to extend
Schedule: M-F 8:30 - 5pm
Responsibilities
- Maintain physical filing systems for QA documentation, including scanning, filing, archiving, and retrieval of controlled records.
- Issue controlled copies of GMP documents following established document control procedures.
- Support organization and archival activities for controlled documents, logbooks, forms, and training records.
- Ensure accuracy, completeness, and legibility of documents prior to filing or issuance.
- Maintain logs and trackers associated with document issuance and filing activities.
- Assist with the review of documents for formatting and compliance with document control expectations.
- Prepare and organize new GMP logbooks for issuance; collect completed logbooks for archival.
- Support QA team members with routine document control tasks as assigned.
- Escalate issues or discrepancies to QA leadership in a timely and appropriate manner.
- Ensure all activities are performed in accordance with GMP, ALCOA principles, and site Quality procedures.
- High school diploma required; Associate’s or Bachelor’s degree preferred.
- Experience working in a GMP or regulated environment preferred.
- Strong attention to detail and accuracy in handling documents and records.
- Ability to follow written procedures and maintain compliance with document control standards.
- Proficient with Microsoft Office (Word, Excel, Outlook).
- Ability to work independently, stay organized, and manage multiple tasks.
- Strong communication and interpersonal skills.
- Demonstrates professional behavior consistent with company policies and ethical standards.
Estimated Min Rate: $21.00
Estimated Max Rate: $30.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice:
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 Validation.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
This role is for Sr. CQV Engineer will require 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. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
The work will require working out of client’s facilities, which are typically in the Greater Denver/Boulder Colorado & surrounding areas.
Responsibilities
- Provide technical guidance in 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, and provide updates.
- Engage other departments, as required, in the 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.
Qualifications
- 12+ years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
- Previous experience in the pharmaceutical / biotech industry, with knowledge of requirements for cGMP operations.
- 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, is considered an asset, but not required.
- 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 qualifications 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 complexities.
- 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
- Ability to lift 50 lbs.
Compensation: 90,000$ - 115,000$ based on experience.
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.
Job Title: Senior Business Analyst
Location: 100% Remote -Jackson, MS
Duration: 06 Months
Description of the job functions the contractor will be expected to perform. The Mississippi Department of Child Protective Services seeks a Senior Business Analyst to support a proof-of concept demonstration using natural language processing and other machine learning methods to improve the intake process. This work is critical to demonstrate the potential of the latest technology to improve the lives of children at risk.
The Senior Business Analyst (SBA) will play a key role in realizing strategic initiatives for the State by optimizing workflows, partnering with customers at all levels of the organization, and collaborating with technical resources to develop tools and methods that improve the intake process. The SBA must possess excellent communication skills, a proven record of delivering meaningful results, and the ability to work in an Agile environment. Furthermore, the SBA should be familiar with the data systems commonly used by Child Protective Services.
Key Responsibilities:
• Ensure the Objectives of the Project are Satisfied
o The SBA will ensure the State’s objectives of protecting children and reducing the use of State resources are maintained throughout the proof-of-concept.
o The SBA will add to the project objectives based on requests from the State.
• Lead Exploratory Interviews, Discovery Sessions, and Workshops
o Organize exploratory interviews, discovery sessions, and workshops with State representatives to understand and document current workflows and shortcomings.
o Identify key stakeholders and document their specific views on the current intake process.
o Work with technical team members to capture the technical implications of the shortcomings.
• Contribute to the Development of a New Intake Process
o Participate in discussions related to the development of the new intake process to ensure the objectives of the State are being met.
o Provide workflow insight; Reconcile the current workflow with the proposed revised workflow. Identify issues and benefits from the user’s perspective.
o Contribute to the development of key metrics associated with measuring the prototype’s efficacy.
o Document as appropriate for the purposes of transparency to the State.
o Provide written and verbal communications to clarify technical points as appropriate.
• Engage State at All Levels
o Partner with key stakeholders at all levels within MDCPS to ensure their understanding, participation, and support of the project.
o Gain support by understanding what is working and what could be improved in the current intake process.
• Ensure Transparency and Communications
o Provide short status reports on a bi-weekly basis and a monthly summary report.
• Coordinate Conference Room Demonstrations
o Organize the conference room demo for key stakeholders.
o Provide the framework for the demonstration to ensure the objectives of the State are satisfied.
o Work with the technical staff to ensure the major functionality of the application is presented and understood by the key stakeholders.
o Document feedback from the demonstration.
• Roadmap
o Contribute to the development of a roadmap that illustrates how the developed technology could be integrated into the State’s ecosystem of technologies and processes.
• Final Report
o Draft a final report of the project documenting all significant aspects.
o Provide a review copy of the report to the State. Capture comments from State officials.
o Update the final report based on comments from State officials. Resubmit the final report.
• Lead the Agile Development Process
o Provide scrum leadership
o Create documentation as agreed on with State representatives
Required Skills/Experience:
• Bachelor’s or Master’s degree in business administration, finance, or a related field.
• Minimum ten (10) years of experience in a business analyst role for either state, local, or corporate clients.
• Proven expertise delivering CCWIS solutions, including but not limited to, intake processes, call center operations processes, and case actioning.
• Working experience on design, configuration, and delivery of at least (2) COTS CCWIS systems, including systems by RedMane Technology.
• An understanding of how to advance a strategy and devise tactics to achieve incremental goals.
• Knowledge of developmental projects related to algorithm design, implementation, and testing is a plus.
• Skilled at conducting workshops, interviews, and discovery sessions.
• Can map workflows, analyze business outcomes, and devise improvements that minimize labor and cost, while improving outcomes using technological tools envisioned in the POC.
• Successful collaboration with technical team members.
• A successful history of using Agile methods to manage complex developments.
• Strong written and verbal communication skills.
• A history of quantifying the value of business outcomes based on measured data.
• Experience identifying key stakeholders, at all levels, and winning their support.
• Prior success in understanding high-level requirements and converting requirements into day-to-day action.
• Skill in managing budgets, scope, project risk, and delivering results.
• Can create clear documentation
About Us:
At Radiant Digital, we provide IT solutions and consulting services to help government agencies and businesses in the USA, Canada, the Middle East, and Southeast Asia. On the federal side, we support agencies like NASA, the Department of State (DOS), the IRS, ACL, ACF,USDA and many others, along with numerous state and local government agencies.
We work with industries like telecom, healthcare, entertainment, oil and gas offering solutions designed to meet their specific needs. We focus on improving systems, making better use of data, and updating applications to keep up with changing markets.
Previous Pharmaceutical/Biotech experience is mandatory for this role.
MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of 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 C&Q Specialist 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 specialists.
The work will require working out of the client’s facilities in Greenville, North Carolina.
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 specifications are met.
- Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
- Experience with C&Q parts washer and autoclave 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: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
- Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
- 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 an asset.
- 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 mentorship skills, to coach and develop junior and intermediate employees.
- Degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, Science or a related discipline.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills
Compensation: 80,000$ -110,000$ based on industry experience.
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.
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 Validation.
MMR Consulting has offices in Canada, USA, and Australia.
This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of engineers involved in the design, commissioning & qualification, start-up and project management of various processes, systems, and facilities. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
This role is for C&Q Manager will require 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. The ideal candidate should possess leadership skills to lead teams of intermediate & junior engineers.
The work will require working out of client’s facilities, which are in Boulder, Colorado.
Responsibilities
- Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, etc.
- 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, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all 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.
- 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: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
- 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, but not required.
- 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.
- Ability to lift 50 lbs.
- Science degree, or equivalent studies such as Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline along with industry experience.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills
Compensation: 90,000$ - 145,000$ based on experience.
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.
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 Consulting has offices in Canada, USA, and Australia.
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.
This role is for CQV 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 work will require working out of the client’s facilities in San Diego, California.
Responsibilities
- Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities used in life science manufacturing, such as bioreactors, tanks, CIP, Buffers, Media, Chrom, TFF, washers & autoclaves, centrifuges, etc.
- 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, 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 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.
- Other duties as assigned by client, and/or MMR, based on workload and project requirements.
Qualifications
- 3-6+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry.
- Engineering or Science degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical or a related discipline.
- Excellent written and spoken English is required including the preparation of technical documents in English
- Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
- 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.
- Ability to lift 50 lbs.
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills
Salary range: 80,000$ -120,000$ based on experience.
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.
Position Overview
The Regional Sales Manager - SF Bay Area & Western Region represents a curated portfolio of premium brands within an assigned territory, serving as the primary field partner to distributors and select dealers. The role centers on two key product lines: one undergoing a significant brand and product refresh following years in market, and another experiencing strong momentum and rapid growth. This position requires thoughtful brand stewardship, strong distributor relationships, and the ability to balance development, education, and sell-through across multiple lines.
This role is based out of the SF Bay Area with travel throughout the greater territory (Western Canada, PNW, Hawaii).
Key Responsibilities
· Represent and manage a curated portfolio of Lunada Bay Corp. brands, with primary focus on two core lines—one in active revitalization and one experiencing rapid growth
· Serve as the face of the Lunada Bay Corp. brands within the territory, building long-term relationships with distributors, dealers, and select trade partners
· Work closely with distributor principals and sales teams to align priorities, training, and in-market execution
· Support dealer and showroom partners through regular visits, product education, merchandising guidance, and hands-on market support
· Make targeted A&D calls in key markets, focusing on strategic firms, designers, and projects that align with brand positioning and distributor capabilities
· Partner with distributor and dealer teams to support specification influence and project pull-through, while recognizing that final project management and order execution reside with the channel
· Drive sell-through with thoughtful support of product launches, brand refresh initiatives, and select local programs
· Develop and execute territory plans that balance growth, brand integrity, and long-term market development
· Collaborate with internal teams including marketing, customer success team, and operations to ensure consistent and high-quality customer experience
· Track activity, opportunities, and performance using CRM and reporting tools
· Represent the Lunada Bay Corp. portfolio at industry events, trade shows, and design-focused functions as appropriate
· Provide ongoing market feedback on product performance, customer needs, and competitive dynamics
Requirements & Qualifications
· Bachelor's degree or 5+ years of outside sales experience representing manufacturers or rep agencies in tile, floor coverings, wall coverings, textiles, or related premium building materials
· Proven ability to manage multiple brands while maintaining focus on priority lines
· Experience supporting brand refreshes, product launches, or growth-stage product lines preferred
· Strong distributor and dealer relationship experience in design-driven or specialty markets
· Comfortable in a field-based role with regular regional travel
· Consultative, relationship-first sales style with attention to detail and brand presentation
· Highly organized and self-directed with strong territory and time management skills
· Proficient with CRM systems and standard business tools
· Polished communication and presentation skills
Pay range and compensation package
- Base salary: Competitive and commensurate with experience in B2B sales and/or inventory-related roles in building materials or similar industries; may be structured appropriately for full-time or part-time employment. Full-time salary range: $60,000 - $80,000 + commission.
- Commission: Sales Commission in addition to base salary.
Lunada Bay Tile is an Equal Opportunity Employer committed to building a diverse workforce. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, or any other legally protected status.
Duration - 6 months
Shift - 08.00 AM to 05.00 PM
Responsibilities:
- Serve as a primary administrator and subject-matter expert for Concur Expense & Concur Travel.
- Provide day-to-day support to employees and managers regarding expense report submissions, approvals, documentation requirements, and system troubleshooting.
- Support Concur audit and compliance workflows, including missing receipt declarations, returned reports, and exception handling.
- Ensure consistent application of corporate T&E policies across all business units.
- Reporting, Analysis & Data Integrity
- Own monthly T&E accrual reporting for US Field, US Manufacturing, and Canada.
- Consolidate and validate spend and aging data across Concur, Oracle, SAP, and related systems.
- Maintain Operational/Compliance dashboards (Excel and/or Power BI) to support spend visibility and leadership reporting.
- Provide ad-hoc analysis for Procurement, Finance, and HR as needed.
Compliance & Governance
Documentation, SOPs & Continuous Improvement
Cross-Functional Collaboration
Required
- Bachelor’s degree in Business, Supply Chain, Accounting, Finance, or a related field.
- 2–4 years of experience in Travel & Expense administration, Accounts Payable, Procurement Operations, or similar function.
- Strong Excel skills (pivot tables, lookups, advanced formulas).
- Hands-on experience with Concur Expense & Travel.
