Top 23376 Process validation engineer Jobs

Sr. Process Engineer
Alcami Corporation —Charleston, SC
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Ability to walk for extended periods
Sr. Process Engineer
Kaztronix —Gainesville, GA
- Full-time
- Microsoft Excel
- 5 years
- Engineering
Quick Apply
Process Engineer
BCP Engineers & Consultants —Oak Ridge, TN
- $80 - $95 an hour
- Overtime
- Hybrid work
- Background check
- 7 years
- Analysis skills
Quick Apply
11d
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
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Chemical Process Engineer
RigUp —Portland, OR
- $72 - $85 an hour
- Temporary
- Engineering
- Continuous improvement
- Mentoring
- Health insurance
- Dental insurance
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2d
Validation Engineer
Validation & Engineering Group, Inc —New Albany, OH
- Full-time
- Engineering
- Mid-level
- Organizational skills
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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 Engineer
Katalyst Healthcares & Life Sciences —Bothell, WA
- Contract
- 5 years
- Engineering
- Senior level
Quick Apply
Process Validation Engineer
Agilent Technologies, Inc. —Frederick, CO
- $105,280 - $164,500 a year
- Full-time
- Bachelor of Science
- 8 years
- Bachelor's degree
Process Validation Engineer
Katalyst Healthcares & Life Sciences —Bloomington, IN
- Contract
- Hybrid work
- Engineering
- Mid-level
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Process Validation & Cleaning Engineer
Amneal Pharmaceuticals —Piscataway, NJ
- $80,000 - $90,000 a year
- Full-time
- Microsoft Word
- Bachelor of Science
- Writing skills
- Health insurance
- 401(k) matching
Process Validation Associate / Engineer
Krystal Biotech —Pittsburgh, PA
- Full-time
- Bachelor's degree
- 1 year
- Communication skills
Quick Apply
Validation Engineer
Zenith LifeScience —South Plainfield, NJ
- $70,000 - $80,000 a year
- Full-time
- 3 years
- Bachelor's degree
- Product management
Validation Engineer
CAI —Boston, MA
- $72,800 - $80,100 a year
- Full-time
- Customer service
- Mid-level
- Team management
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Validation Engineer - Upstream
Validation & Engineering Group, Inc —Punta Santiago, PR
- Extended hours
- Engineering
- Mid-level
- 3 years
Quick Apply
Process Engineer
Katalyst Healthcares & Life Sciences —Antioch, IL
- Contract
- 7 years
- Bachelor of Science
- English
Quick Apply
Validation Engineer
VERAZ INC —Boston, MA
- $30 - $45 an hour
- Full-time
- In-person
- 1 year
- Electrical Engineering
- Relocation assistance
- Health insurance
Quick Apply
4d
Process Engineer
Viant Medical —Remote
- Full-time
- Spanish
- Word processing
- Bachelor of Science
Quick Apply
Senior Validation Engineer
Katalyst Healthcares & Life Sciences —Rock Hill, SC
- Weekends as needed
- Hybrid work
- Bachelor's degree
- Senior level
Quick Apply
Senior CQV Engineer/Senior Validation Engineer Consultant
Katalyst Healthcares & Life Sciences —Devens, MA
- Weekends as needed
- Bachelor's degree
- Continuous improvement
- Senior level
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

Sr. Process Engineer

Sr. Process Engineer

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Process Validation Engineer

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Senior CQV Engineer/Senior Validation Engineer Consultant

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