Top 11638 Manager Process Validation Jobs

Validation Manager
Hikma Pharmaceuticals —Bedford, OH
- $92,850 - $133,750 a year
- Full-time
- OSHA
- Engineering
- Research
- Health insurance
- Dental insurance
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3d
Product Process Validation Manager
Kindeva Drug Delivery Careers —Bridgeton, MO
- Full-time
- 7 years
- Engineering
- Analysis skills
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Manager, Maintenance Systems
Voyant Beauty —Remote
- $150,000 - $165,000 a year
- Full-time
- 7 years
- Engineering
- Analysis skills
- Opportunities for advancement
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11d
Documentation Manager
Clinical Ink —Remote
- 5 years
- Bachelor's degree
- Organizational skills
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Manager, GMP Quality
SimulStat —Remote
- Contract
- Bachelor's degree
- Senior level
- Communication skills
Manager, Validation
ImmunityBio —Dunkirk, NY
- $144,000 - $160,000 a year
- Full-time
- Ability to lift 50 pounds
- Bachelor's degree
- Mentoring
- AD&D insurance
- Disability insurance
Lead Data Manager
DR VINCE CLINICAL RESEARCH PROPOSAL 1 —Remote
- Remote
- System design
- High school diploma or GED
- Mentoring
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9d
Senior Manager, Reference Standards & Reagents
Vera Therapeutics, Inc. —Remote
- $125,000 - $185,000 a year
- Remote
- Bachelor of Science
- 3 years
- Bachelor's degree
- Paid holidays
- Health insurance
Process Manager
Pinnaql —Barceloneta, PR
- Extended hours
- Engineering
- Travel
- Senior level
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Manager, QA Validation (Sterile Manufacturing)
MannKind Corporation —Danbury, CT
- $116,000 - $174,000 a year
- Engineering
- 3 years
- Project management
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Document Control Manager
Rani Therapeutics —Fremont, CA
- $139,409 - $190,000 a year
- 5 years
- Computer literacy
- Organizational skills
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8d
Validation Team Manager (Raleigh, NC)
Eupry —Raleigh, NC
- Full-time
- Engineering
- English
- Office
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Senior Project Manager, Clinical Trials
Cogstate —Remote
- $125,000 - $135,000 a year
- Full-time
- Remote
- Nursing
- 7 years
- Computer Science
- Paid holidays
- Disability insurance
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Sr. Manager, GMP Quality Assurance
Deciphera Pharmaceuticals —Waltham, MA
- $138,000 - $190,000 a year
- Full-time
- Remote
- 8 years
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
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Validation, Quality & Compliance Lead
BULLFROG AI MANAGEMENT LLC —Gaithersburg, MD
- $130,000 - $160,000 a year
- Full-time
- Remote
- 5 years
- US work authorization
- Senior level
- Paid holidays
- Disability insurance
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Computer System Validation Manager
Ofni Systems —Raleigh, NC
- Computer science
- Computer Science
- Bachelor of Science
Manager, Validation
Boehringer Ingelheim Animal Health USA —Saint Joseph, MO
- Full-time
- Management
- Bachelor's degree
- Senior level
Quality Manager
Hill Data Management —New York, NY
- Part-time
- 7 years
- Bachelor's degree
- Quality control
Manager/Sr. Manager, R&D Quality
TG Therapeutics —Remote
- Email
- Remote
- 5 years
- Analysis skills
- Bachelor's degree
Project Manager, Clinical Trials
Cogstate —New Haven, CT
- $105,000 - $120,000 a year
- Full-time
- Remote
- Computer Science
- Master's degree
- Psychology
- Paid holidays
- Disability insurance
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Validation Manager

Hikma Pharmaceuticals
Bedford, OH

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Job Details

Full-time
$92,850 - $133,750 a year
3 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
Life insurance

Qualifications

OSHA
GMP
Pharmaceutical company experience
Requirements analysis
Project scheduling
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Position Summary

The Validation Manager is responsible for the Validation Master Plan (VMP) and managing qualifications and re-qualifications. This includes the review and approval of validation protocols, reports, and related documentation such as: User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as well as Re-qualification (RQ) of process equipment, facility equipment and utility systems. Responsibility encompasses completion of validation activities that meet the requirements of the cGMP's as well as the pharmaceutical industry standards and comply with site validation policy.

Key Responsibilities

· Coordinate and maintain critical validation responsibilities such as planning, scheduling, identifying resource requirements (people and equipment), coordinating with other departments, and ensuring compliance with applicable VMPs.

· Provides input to, reviews and approves User Requirements Specifications (URS).

· Review and approves protocols including Cycle Development Protocols, Investigational/Engineering Study Protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).

· Provides input to Engineering on the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and Commissioning protocols.

· Researches equipment and processes, and establishes parameters and methods to test equipment to meet validation requirements.

· Ensures an effective coordination of the execution of qualifications and all aspects of the validation project with other departments, including but not limited to: Operations, Engineering, Quality Control and Quality Assurance.

· Ensures that the execution of protocols and all related documentation is in compliance with current Good Documentation Practices.

· Ensures equipment used for qualification purposes is properly maintained and calibrated.

· Supports and participates in change control process for critical system/equipment updates and repairs performed through the Work Order control mechanisms. Fully understands the requirements of each change control procedure.

· Assists in equipment troubleshooting and the use of problem solving techniques to resolve issues that could impact the validated state of equipment.

· Performs other duties as assigned and required.

· Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

· Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Requirements

· 4-6 years of validation experience in the pharmaceutical or other GMP-regulated industry

· Experience with aseptic processes is preferred

· Bachelor’s Degree in engineering, science or another discipline with equivalent work experience

· Knowledge of Microsoft Project, Trackwise, AMMS preferred

· Demonstrated ability to communicate effectively with others

Physical Requirements of the Role

Position is exposed to plant environment. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 25 lbs. Standing, walking, bending over and repetitive use of legs are done occasionally.

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may affect the safety or quality of a drug product shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Pay: $92,850.00 - $133,750.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Work Location: In person

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Refine Your Search

Manager Process Validation jobs

Validation Manager

Product Process Validation Manager

Manager, Maintenance Systems

Documentation Manager

Manager, GMP Quality

Manager, Validation

Lead Data Manager

Senior Manager, Reference Standards & Reagents

Process Manager

Manager, QA Validation (Sterile Manufacturing)

Document Control Manager

Validation Team Manager (Raleigh, NC)

Senior Project Manager, Clinical Trials

Sr. Manager, GMP Quality Assurance

Validation, Quality & Compliance Lead

Computer System Validation Manager

Manager, Validation

Quality Manager

Manager/Sr. Manager, R&D Quality

Project Manager, Clinical Trials

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