Top 1306 Validation engineer Jobs in Waltham Ma

Sr. Engineer - Process Development
Yoh, A Day & Zimmermann Company —Waltham, MA
- $33.60 - $48.00 an hour
- Contract
- Master's degree
- Bachelor's degree
- Continuous improvement
- Health savings account
- Disability insurance
Quick Apply
Quality Engineer (ISO 13484)
Commonwealth Sciences —Boston, MA
- Engineering
- Mid-level
- 3 years
Quick Apply
7d
Design Assurance Engineer / Class II Medical Devices
Motion Recruitment —Marlborough, MA
- Full-time
- Microsoft Word
- Microsoft Excel
- Engineering
- Health savings account
- Health insurance
11d
Design Assurance Engineer / Medical Devices
Motion Recruitment —Marlborough, MA
- Full-time
- Microsoft Excel
- Mid-level
- 3 years
7d
Lead Materials Engineer
New Balance —Lawrence, MA
- $117,400 - $186,600 a year
- Full-time
- Hybrid work
- Office
- Travel
- Organizational skills
- Disability insurance
- Health insurance
Lead Computer Systems Validation Engineer I (Clinical & R&D)
Alkermes, Inc. —Waltham, MA
- Full-time
- Psychiatry
- Bachelor's degree
- Neurology
14d
Sr. Validation Engineer I
QABASA Professionals —Woburn, MA
- Email
- Mid-level
- Master's degree
- Databases
- Paid training
- Relocation assistance
Sr. Validation Engineer I (Pharma)
QABASA Professionals —Woburn, MA
- Email
- Mid-level
- Master's degree
- Databases
- Paid training
- Relocation assistance
6466 - Lab IT Support Engineer (Win11 upgrade) / Senior Validation Engineer
Verista, Inc. —Cambridge, MA
- $83.70 an hour
- Contract
- Laboratory experience
- Mid-level
- Windows
- Commuter assistance
- Paid parental leave
Quick Apply
Validation Engineer
Syner-G —Boston, MA
- Mid-level
- Residential
- 3 years
- Paid holidays
- Paid time off
Staff Validation Engineer
Drägerwerk AG & Co. KGaA —Andover, MA
- $135,325 a year
- Hybrid work
- 3 years
- Travel
- Mentoring
- Free parking
- Paid holidays
7d
Lab Support Engineer
Katalyst Healthcares & Life Sciences —Waltham, MA
- Contract
- Computer science
- Computer Science
- Mid-level
Quick Apply
Sr Engineer, Validation
Emergent BioSolutions —Canton, MA
- $129,000 - $156,000 a year
- Microsoft Excel
- Bachelor of Science
- 8 years
14d
Software Test Engineer - Medical Device Integration (Bedford, MA)
Philips —Bedford, MA
- $115,000 - $182,000 a year
- Full-time
- Computer Science
- Mid-level
- Office
- Health savings account
- Employee stock purchase plan
Validation Engineer
Katalyst Healthcares & Life Sciences —Boston, MA
- Contract
- Engineering
- Senior level
- Leadership
Quick Apply
7d
Validation Engineer 2 - Product R&D
Merck KGaA —Bedford, MA
- $84,900 - $127,300 a year
- Mid-level
- 3 years
- Product management
- Health insurance
- Paid time off
Associate Manager, Systems Engineer, IT
Agios Pharmaceuticals —Cambridge, MA
- $94,025 - $141,038 a year
- On call
- Hybrid work
- Computer science
- Computer Science
- 5 years
- Health insurance
Validation Engineers
Biometrix —Prides Crossing, MA
- Customer service
- Bachelor of Science
- Engineering
- Health insurance
- Dental insurance
Engineer, Quality Engineering
Analog Devices —Wilmington, MA
- $75,200 - $103,400 a year
- Full-time
- Mid-level
- Master's degree
- Travel
- Paid holidays
- Health insurance
Staff Catheter Engineer
Stryker —Waltham, MA
- $107,200 - $178,600 a year
- Full-time
- Mid-level
- 4 years
- Health savings account
- AD&D insurance

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validation engineer jobs near waltham ma

Sr. Engineer - Process Development

Yoh, A Day & Zimmermann Company -
Waltham, MA

Quick Apply

Job Details

Contract
$33.60 - $48.00 an hour

Benefits

Health savings account
Disability insurance
Health insurance
Dental insurance
401(k)
Employee assistance program
Vision insurance
Referral program

Qualifications

Records management
Batch records

Full Job Description

Primary Duties: The Sr. Engineer reports to Principal Engineer and is an integral part of mRNA Drug Substance Process Development team. This position offers opportunities to focus on mRNA drug substance process development, manufacturing, regulatory and analytical support, validation, and data review for drug substances and drug products. The Engineer is responsible for leading and assisting the development and execution of scalable and robust processes for drug substance. This position will act as a Subject Matter Expert (SME) for process knowledge transfer for drug substance to support current Good Manufacturing Practices (cGMP) manufacturing.

Responsibilities include but are not limited to:
40%

-

Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality

Scale-up:
Lead/Perform process scale-up and Pilot batches
Generate and execute scale down models for GMP manufacturing
Generate scale-down models to assist with process scale-up

40%

-

Lead and assist implementation of Digital Tools
Lead implementation of digital tools for process data acquisition (Electronic lab notebooks and Electronic Batch Records.)

10%

-

Lead project activities for the design of mRNA manufacturing processes by contributing and reviewing of Batch Records/Master Production Records (MBR) and Standard Operating Procedures (SOPs).

Document Generation
Author and review MBRs
Author and review SOPs
Effectively communicate with cross functional teams like Manufacturing Analytical

5%

-

Development, R&D, Process Development, Quality Assuance (QA), Project Management, Regulatory Affairs and Legal teams.

Work with internal and external manufacturing on harmonization of electronic batch records.
Work with Digital team withing PD and CMC on the implementation of eBRs and data capture strategy.
Obtain processes from R&D and PD and implement at-scale.
Generate procedures (SOPs, MBRs, Protocols) and work with QA on review and approval
Review and follow QA procedures.

5%

-

Assist in the preparation of technical reports and presentations that support scale-up activities and process improvements

Technical reports (2.5%)
Generate/review Technical reports such as batch summaries, process descriptions, Tech transfer, etc.

Presentations (2.5%)

Present on batch performance, technical issues, etc.

Education and Experience Requirements:
-

6+ (Masters) or 8+ (Bachelors) years of relevant experience is required.
A Bachelor’s degree and/or Master’s degree in Chemical engineering, Biomedical engineering or related field.

Key Skills, Abilities, and Competencies:
-

Demonstrated experience in process development, tech transfer, and/or scale-up to support the manufacturing of biopharmaceuticals is required.
Experience in biopharmaceutical manufacturing, MSAT, and/or Process Development (PD) is required (4+ years).
Experience with mRNA Drug Substance is strongly preferred.
Experience implementing and maintaining electronic batch records (eBRs) is required (1+ years). Experience using Tempo Apprentice strongly preferred.

Estimated Min Rate: $33.60
Estimated Max Rate: $48.00

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 https://www.yoh.com/applicants-with-disabilities 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: https://www.yoh.com/privacy-notice

Stay Safe During Your Job Search
Fraudulent recruiting communications have become increasingly common. Emails from Yoh recruiters will only come from an @yoh.com email address. Yoh will never ask candidates to pay fees, purchase equipment, send gift cards, or transfer funds as part of the recruiting or hiring process. If you receive a communication that appears suspicious or requests payment, contact Yoh directly before responding or sharing personal information.
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validation engineer jobs in waltham ma

Sr. Engineer - Process Development

Quality Engineer (ISO 13484)

Design Assurance Engineer / Class II Medical Devices

Design Assurance Engineer / Medical Devices

Lead Materials Engineer

Lead Computer Systems Validation Engineer I (Clinical & R&D)

Sr. Validation Engineer I

Sr. Validation Engineer I (Pharma)

6466 - Lab IT Support Engineer (Win11 upgrade) / Senior Validation Engineer

Validation Engineer

Staff Validation Engineer

Lab Support Engineer

Sr Engineer, Validation

Software Test Engineer - Medical Device Integration (Bedford, MA)

Validation Engineer

Validation Engineer 2 - Product R&D

Associate Manager, Systems Engineer, IT

Validation Engineers

Engineer, Quality Engineering

Staff Catheter Engineer

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