Top 183 Process validation scientist Jobs in Boston, Ma

Product Development Engineering Scientist
Vertex Pharmaceuticals —Boston, MA
- $105,600 - $158,400 a year
- Full-time
- Bachelor of Science
- Mid-level
- 2 years
- Loan repayment program
- Dental insurance
Product Development Engineering Senior Scientist - Medical Device & Combination Products
Vertex Pharmaceuticals —Boston, MA
- $126,600 - $189,800 a year
- Full-time
- Bachelor of Science
- Engineering
- Bachelor's degree
- Loan repayment program
- Dental insurance
Analytical Principal Research Scientist
Vertex Pharmaceuticals —Boston, MA
- $140,800 - $211,200 a year
- Full-time
- Writing skills
- Master's degree
- Bachelor's degree
- Loan repayment program
- Dental insurance
Senior Scientist, Data Science - Hybrid
XPO —Boston, MA
- $106,383 - $132,978 a year
- Full-time
- Computer Science
- Military
- Pass drug screening
- Paid holidays
- Disability insurance
Research Associate, Technical Operations
Flagship Pioneering, Inc. —Cambridge, MA
- $65,000 - $93,500 a year
- Bachelor's degree
- Continuous improvement
- Organizational skills
- Retirement plan
2d
Quality Control Analyst (Multiple Openings)
CRISPR Therapeutics, Inc. —Framingham, MA
- $93,000 - $103,000 a year
- Full-time
- Mid-level
- 3 years
- Bachelor's degree
Quick Apply
Clincal Lab Scientist
PREDICTA BIOSCIENCES INC —Cambridge, MA
- $75,000 - $110,000 a year
- Full-time
- Mid-level
- Office
- Master's degree
- Health savings account
- Health insurance
Quick Apply
8d
QC Senior/Principal Scientist, Analytical Method Validation
Genezen —Lexington, MA
- $120,000 - $160,000 a year
- Microsoft Word
- Computer literacy
- 8 years
- Health savings account
- AD&D insurance
Quick Apply
Senior Scientist I, Quality Control
Candel Therapeutics —Needham, MA
- $155,000 - $160,000 a year
- Full-time
- Doctor of Philosophy
- US work authorization
- Computer skills
12d
Principal Scientist Biophysical Characterization
Eli Lilly —Boston, MA
- $71,250 - $187,000 a year
- Full-time
- Bachelor of Science
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
Food Scientist
Pueo Business Solutions LLC —Natick, MA
- Full-time
- ServSafe
- Customer service
- Research
Research Associate, Analytical Chemistry
Manus —Waltham, MA
- Full-time
- Bachelor of Science
- Mid-level
- Analysis skills
- Opportunities for advancement
Quick Apply
Data Coordinator II, Research_BIDMC
Beth Israel Lahey Health —Boston, MA
- $21.64 - $34.62 an hour
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Hospital
MSAT Process Science Senior Scientist, Investigations
Vertex Pharmaceuticals —Boston, MA
- $120,800 - $181,200 a year
- Full-time
- Hybrid work
- 5 years
- Engineering
- Master's degree
- Loan repayment program
- Dental insurance
12d
Senior Process Development Scientist III
Sun Pharmaceutical Industries, Inc (USA) —Billerica, MA
- $102,500 - $113,500 a year
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Disability insurance
- Health insurance
Process Development Principal Scientist
Amgen —Cambridge, MA
- $141,836.95 - $191,897.05 a year
- 6 years
- Management
- Analysis skills
- Disability insurance
- Health insurance
9d
Senior Scientist, Analytical Development
Aurion Biotech Inc. —Cambridge, MA
- $155,000 - $170,000 a year
- Research
- 3 years
- Doctor of Philosophy
- Health insurance
- Flexible spending account
Principal Scientist, Analytical Sciences
Eli Lilly —Watertown, MA
- $71,250 - $187,000 a year
- Full-time
- Bachelor of Science
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
10d
Principal Scientist - CMC Statistician
Sanofi —Framingham, MA
- $122,250.00 - $176,583.33 a year
- 6 years
- Master's degree
- Math
- Parental leave
Senior Research Scientist
ICON Plc —Cambridge, MA
- $91,336 - $114,170 a year
- Full-time
- Doctor of Philosophy
- In-person
- Senior level
- Disability insurance
- Health insurance
4d

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process validation scientist jobs near boston, ma

Product Development Engineering Scientist

Vertex Pharmaceuticals -
Boston, MA

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Job Details

Full-time
$105,600 - $158,400 a year

Benefits

Loan repayment program
Dental insurance
Tuition reimbursement
Paid time off
Vision insurance
401(k) matching

Qualifications

Statistics
Content creation for technical audiences
Statistical analysis
Technical writing experience within technology
Manufacturing company experience

Full Job Description

Job Description

General Summary:

The Product Development Engineering Scientist focuses on combination product development, with a particular focus on drug delivery systems. The Product Development Engineering Scientist will work closely with Research and Development, Device Quality Control, Device Quality Assurance, Process Development, Clinical/Commercial Packaging & Labeling Functions, Regulatory Affairs, and Manufacturing Functions, as required.

Key Duties and Responsibilities:

Collaborate with highly cross-functional teams to author the design history documentation of combination drug-device and/or biologic device products.
Author Risk Analyses, including DFMEA, UFMEA, PFMEA, and biocompatibility risk assessments.
Translates User Requirements into Design Requirements as appropriate. Correlates Design Inputs with Design Outputs and supports Design Verification and Validation Studies (as needed) to be executed both internally and externally.
Manage Change Control, Deviations and Non-conformances with Cross-Functional Team for Impact Assessment and Investigations, and manage timely completion of activities while ensuring updates are made to relevant documents in Design History File.
Perform Design History File maintenance as required, including – as applicable – review and revision of all Design and Quality System Documentation.
Display an eye for completeness, ensuring enough detail is captured for Process Development and Manufacturing purposes. Aligns with User Requirements, Functional Requirements, and Design Inputs as appropriate.

Knowledge and Skills:

Proven experience with Medical Device Development including ownership and/or authorship of Design and Development file records and Risk Management deliverables.
Experience with medical device packaging development and mechanical performance testing is preferred.
Working knowledge of Test Methods for selection, verification and validation of components, sub-systems and assemblies.
Able to present to cross-functional team for input, alignment, and design and risk file updates.
Must have experience executing workstreams in highly matrixed environments.
A strong understanding of cGxP principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.
A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.

Education and Experience:

B.S or M.S in engineering or another relevant discipline.
2 years of experience working within a medical device environment.

Pay Range:

$105,600 - $158,400

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

On-Site Designated

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]

Apply Now

Refine Your Search

process validation scientist jobs in boston, ma

Product Development Engineering Scientist

Product Development Engineering Senior Scientist - Medical Device & Combination Products

Analytical Principal Research Scientist

Senior Scientist, Data Science - Hybrid

Research Associate, Technical Operations

Quality Control Analyst (Multiple Openings)

Clincal Lab Scientist

QC Senior/Principal Scientist, Analytical Method Validation

Senior Scientist I, Quality Control

Principal Scientist Biophysical Characterization

Food Scientist

Research Associate, Analytical Chemistry

Data Coordinator II, Research_BIDMC

MSAT Process Science Senior Scientist, Investigations

Senior Process Development Scientist III

Process Development Principal Scientist

Senior Scientist, Analytical Development

Principal Scientist, Analytical Sciences

Principal Scientist - CMC Statistician

Senior Research Scientist

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