Validation Engineer - Pharmaceutical Manufacturing - 6+ Yrs - Fall River, Massachusetts 

​The Manufacturing Validation Engineer is responsible for the creation and revision of new and existing GMP, project handle, qualification & validation documents preparation and execution. In this role the Validation Engineer adheres to the company’s document and SOP’s procedures while ensuring their accuracy, quality, and integrity. This position reports to the Manufacturing/Packaging and partners with cross functional team members to ensure compliance and operational success through user focused documentation.

Location: Fall River, MA, 02720

Your Future Employer: 

Engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with emphasis in several therapeutic areas including cardiovascular, anti-infectives, CNS, anti-inflammatory, anti-diabetics, and anti-depressants. Dedicated in providing high-quality branded and generic medicines.    

Responsibilities:   

1.      Validation Lifecycle Management: Lead the end-to-face qualification and validation of equipment, computer systems, and processes, including the preparation and execution of URS, DQ, IQ, OQ, and PQ documents.

2.      Cleaning & Process Validation: Develop robust strategies and documentation for cleaning and process validation of API equipment to ensure compliance with site SOPs and FDA regulatory guidance.

3.      System Digitalization: Oversee the preparation and qualification of electronic batch records (e-batch) and e-Log Books, ensuring 21 CFR Part 11 compliance regarding electronic signatures and reports.

4.      Continuous Improvement & RCA: Autonomously manage projects for process optimization and lead root cause investigations into performance trends or formal deviations using tools like FMECA.

5.      Audit Readiness & Compliance: Defend validation programs and strategies during regulatory audits and perform weekly quality reviews of the Master Control database to ensure document integrity and GDP (Good Documentation Practices).

Requirements:   

1.      Educational Background: A Bachelor’s or Master’s degree in Pharmaceutical Engineering, Science, or a related field (Associate’s degree acceptable with 4–6 years of specific GMP experience).

2.      Validation Expertise: In-depth knowledge of the validation "V-Model" (URS, FDS, FAT/SAT, RTM) and practical experience with automation and computer system validation (CSV).

3.      Industry Experience: Minimum of 4 years in documentation and 6 years in the pharmaceutical/biotech industry, with a strong preference for generic manufacturing or inhalation products (MDI).

4.      Regulatory Knowledge: Deep understanding of cGMP, 21 CFR Part 11, and specialized software systems including SAP, Master Control, and TrackWise.

5.      Analytical & Investigative Skills: Proven ability to facilitate problem-solving for complex technical issues and handle high-pressure regulatory audits at local and federal levels.

What's in it for you?   

Exciting growth opportunities, a dynamic work environment, and stable project work that strengthens both functional and cross-functional skills. A well-structured workplace that offers stability, competitive benefits, and a supportive environment that enhances both productivity and work-life balance. Strong opportunities for career growth through exposure to modern technologies and continuous skill development.

Reach us: If you feel this opportunity is well aligned with your career progression plans, please feel free to reach out to me with your updated profile at twinkle@crescendo-global.com   

Disclaimer: Crescendo Global is specializes in Senior to C-level niche recruitment. We are passionate about empowering job seekers and employers with an engaging memorable job search and leadership hiring experience. Crescendo Global does not discriminate on the basis of race, religion, color, origin, gender, sexual orientation, age, marital status, veteran status, or disability status.   

Note: We receive a lot of applications on a daily basis, so it becomes a bit difficult for us to get back to each candidate. Please assume that your profile has not been shortlisted in case you don't hear back from us in 1 week. Your patience is highly appreciated.   

Scammers can misuse Crescendo Global’s name for fake job offers. We never ask for money, purchases, or system upgrades. Verify all opportunities at www.crescendo-global.com and report fraud immediately. Stay alert!   

Profile Keywords: IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), URS (User Requirement Specification), FDS (Functional Design Specification), VMP (Validation Master Plan), Cleaning Validation, API Equipment, Process Validation, Periodic Review, 21 CFR Part 11, GAMP 5, Electronic Batch Records (eBR), TrackWise, MasterControl, SAP, Change Control, CAPA, cGMP, GDP (Good Documentation Practices), FDA Audit Defense, FMECA (Failure Mode, Effects, and Criticality Analysis), Root Cause Analysis (RCA).