Top 26426 Process/validation engineers Jobs

Sr. Process Engineer
Alcami Corporation —Charleston, SC
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Ability to walk for extended periods
Injection Molding Process Engineer / Technician (1 year experience preferred)
Midwest Molding Inc —Plain City, OH
- $70,000 - $100,000 a year
- Full-time
- ERP systems
- Mid-level
- Mentoring
- Paid holidays
- Health insurance
Quick Apply
Design Engineers - multiple job openings; Trevor, WI and Fortville, IN
Vonco Products LLC —Trevor, WI
- $80,000 - $95,000 a year
- Full-time
- Ability to walk for extended periods
- Bachelor of Science
- Engineering
Quick Apply
14d
Process Validation Engineer or Specialist I, II, III, or Sr.
Grand River Aseptic Manufacturing, Inc. —Grand Rapids, MI
- Day shift
- Microsoft Excel
- Microsoft Outlook
- Engineering
- Paid holidays
- Dental insurance
Quick Apply
Process Engineer - R&I
American Spraytech, LLC —Branchburg, NJ
- $80,000 - $98,000 a year
- Full-time
- Engineering
- Mid-level
- Analysis skills
Quick Apply
Validation Engineers
Biometrix —Prides Crossing, MA
- Customer service
- Bachelor of Science
- Engineering
- Health insurance
- Dental insurance
Process Validation/Equipment Engineers
PROFOUND DEVELOPMENT GROUP —Loveland, OH
- Mid-level
Process Validation Associate / Engineer
Krystal Biotech —Pittsburgh, PA
- Full-time
- Bachelor's degree
- 1 year
- Communication skills
Quick Apply
Process Validation Engineer
Valspec —San Diego, CA
- $75 - $85 an hour
- Bachelor of Science
- 8 years
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Quick Apply
Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $70,000 - $80,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
Process Engineer III - Contract Role
Kinetic Personnel Group, Inc. —Marlborough, MA
- $65 - $70 an hour
- Temporary
- 7 years
- Office
- Bachelor's degree
Quick Apply
Lead Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $136,000 a year
- Full-time
- 3 years
- Master's degree
- Databases
Validation Engineer
VERAZ INC —Boston, MA
- $30 - $45 an hour
- Full-time
- In-person
- 1 year
- Electrical Engineering
- Relocation assistance
- Health insurance
Quick Apply
8d
Computer System Validation Engineer
Katalyst Healthcares & Life Sciences —New Wilmington, PA
- Contract
- 8 years
- Senior level
Quick Apply
Validation Engineer II
Cadence Inc —Suffield, CT
- $83,800 - $105,000 a year
- 8 hour shift
- Engineering
- Mid-level
- Office
Quick Apply
Validation Engineer
OPULENTSOFT —Northridge, CA
- Email
- Bachelor of Science
- Mid-level
- Communication skills
Validation Engineer
Katalyst Healthcares & Life Sciences —Waltham, MA
- Contract
- Mid-level
- Budgeting
- Communication skills
Quick Apply
Validation Engineer
FATHOM LIFE SCIENCES & TECHNOLOGY SERVICES —Fremont, CA
- Full-time
- Mid-level
- Bachelor's degree
- 1 year
Validation Engineer / CQV Engineer
Katalyst Healthcares & Life Sciences —Cincinnati, OH
- Contract
- Engineering
- Mid-level
Quick Apply
Sr. Validation Engineer I
AM Logic Corporation —Edison, NJ
- $104,000 - $110,000 a year
- Email
- Databases
- SharePoint
- Senior level

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process/validation engineers jobs near

Sr. Process Engineer

Alcami Corporation -
Charleston, SC

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Job Details

Full-time

Qualifications

Customer communication
Microsoft Excel
Microsoft Outlook
Word embeddings
Manufacturing facility experience
Pharmaceutical company experience
Pharmaceutical manufacturing facility experience

Full Job Description

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

Job Summary:

The Sr. Process Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial parenteral Drug Product manufacturing. The Sr. Process Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and coordinating lab studies with the formulation development lab. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

On-Site Expectations:

100% on-site position.
1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities:

Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects.
Writes Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
Author manufacturing investigations and complete CAPA assignments.
Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products.
Interact with clients during routinely scheduled project meetings.
Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
Other duties as assigned.

Qualifications:

Bachelor’s degree in Engineering, Pharmacy, or Chemistry.
5 years of experience of technical support in a sterile pharmaceutical manufacturing environment.
Previous experience supporting tech transfer of parenteral Drug Products preferred.

Knowledge, Skills, and Abilities:

Excellent verbal communication, written communication, documentation, negotiation, critical thinking, analytical, problem solving, detail orientation, organization and time management skills required.
Working knowledge of cGMP requirements related to sterile Drug Product manufacturing processes.
Working knowledge of EU regulations preferred.
Proficiency with Microsoft office (Word, Excel, Outlook) required.
Ability to interact with internal stakeholders and external customers.

Travel Expectations:

Up to 5% domestic travel.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to frequently stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance; and taste or smell. The employee must frequently lift and/or move up to 25 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.

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Refine Your Search

process/validation engineers jobs

Sr. Process Engineer

Injection Molding Process Engineer / Technician (1 year experience preferred)

Design Engineers - multiple job openings; Trevor, WI and Fortville, IN

Process Validation Engineer or Specialist I, II, III, or Sr.

Process Engineer - R&I

Validation Engineers

Process Validation/Equipment Engineers

Process Validation Associate / Engineer

Process Validation Engineer

Validation Engineer

Process Engineer III - Contract Role

Lead Validation Engineer

Validation Engineer

Computer System Validation Engineer

Validation Engineer II

Validation Engineer

Validation Engineer

Validation Engineer

Validation Engineer / CQV Engineer

Sr. Validation Engineer I

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