Top 27862 Process validation engineer Jobs

Sr. Process Engineer
Alcami Corporation —Charleston, SC
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Ability to walk for extended periods
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 Engineer
Weiss-Aug MedPharma —Fairfield, NJ
- $100,000 - $110,000 a year
- Full-time
- Microsoft Excel
- 5 years
- Engineering
- Health savings account
- Disability insurance
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Process Engineer
Feintool —Antioch, TN
- $75,000 - $100,000 a year
- Full-time
- Mid-level
- 3 years
- Analysis skills
- Paid holidays
- Disability insurance
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Process Engineer III
Astrix Technology Group —Marlborough, MA
- $50 - $67 an hour
- Contract
- 7 years
- Bachelor's degree
- Travel
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AI Business Process Engineer
signitives IT Solutions —Remote
- $65 - $70 an hour
- Contract
- Remote
- Mid-level
- Agile
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Validation Engineer
VERAZ INC —Boston, MA
- $30 - $45 an hour
- Full-time
- In-person
- 1 year
- Electrical Engineering
- Relocation assistance
- Health insurance
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4d
Process Validation Associate / Engineer
Krystal Biotech —Pittsburgh, PA
- Full-time
- Bachelor's degree
- 1 year
- Communication skills
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Validation Engineer - Upstream
Validation & Engineering Group, Inc —Juncos, PR
- Extended hours
- Engineering
- Mid-level
- 3 years
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Validation Engineer
Validation & Engineering Group, Inc —Atlanta, GA
- Full-time
- Engineering
- Mid-level
- Organizational skills
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CSV Validation QC Engineer
supremesoft —Jersey City, NJ
- 7 years
- Quality control
- Senior level
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Lead Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $136,000 a year
- Full-time
- 3 years
- Master's degree
- Databases
Validation DevOps Engineer
UST —Redmond, WA
- $72,000 - $108,000 a year
- Remote
- Azure
- 5 years
- DevOps
- Paid jury duty
- Health savings account
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Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $70,000 - $80,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
Process Engineer
Viant Medical —Remote
- Full-time
- Spanish
- Word processing
- Bachelor of Science
Quick Apply
CQV/Validation Engineer
Sebela Pharmaceuticals Inc. —Holbrook, MA
- $33 - $43 an hour
- Overtime
- AutoCAD
- Mid-level
- Communication skills
Quick Apply
Validation Engineer / CQV Engineer
Katalyst Healthcares & Life Sciences —Cincinnati, OH
- Contract
- Engineering
- Mid-level
Quick Apply
Senior Process Development Engineer
Nektar Therapeutics —Remote
- $170,000 - $190,000 a year
- 8 years
- Travel
- Fair chance
- Employee stock purchase plan
- Paid holidays
Associate/Validation Engineer
Precigen, Inc —Germantown, MD
- $75,000 - $105,000 a year
- Full-time
- Ability to walk for extended periods
- Engineering
- Data analysis skills
Quick Apply
Validation Engineer
Validation & Engineering Group —Raleigh, NC
- Full-time
- 5 years
- Engineering
- Continuous improvement
Quick Apply

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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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process validation engineer jobs

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