Mfg. Validation Engineer

Job Title: Mfg.

Validation Engineer

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: General Shift: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: Manufacturing Manager

Salary Range: $62,400 - $75,400

The content and statements documented in this job description are designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job.

Invagen Pharmaceuticals is searching for experienced candidates for the position of Manufacturing Validation Engineer.

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 procedures while ensuring their accuracy, quality, and integrity. This position reports to the Manufacturing/Packaging Manager and partners with cross‑functional team members to ensure compliance and operational success through user‑focused documentation at Inva Gen Pharmaceuticals, Inc.,

Fall River, MA.

• Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets, and generates and reports on metrics on an agreed frequency.
• Creates training materials for subject matter input.
• Tracks and manages periodic review.
• Develops strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.
• Autonomously leads and manages projects to implement continuous improvement opportunities.
• Leads and/or supports root‑cause investigations related to performance trends and formal deviations.
• Develops, implements, and assesses solutions for complex problems; anticipates risk and builds contingencies to help mitigate impact.
• Reviews documents for accuracy and completeness.
• Defends the validation programs and strategies to customers and regulatory auditors.
• Performs weekly quality reviews of the Master Control database by ensuring new documents have been entered using appropriate protocols.
• Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as current Good Manufacturing Practices (cGMP), complying with legal regulations and monitoring the environment.
• Performs other duties as assigned.
• Possesses knowledge of qualification and validation documents.
• Prepares qualification and validation documents for equipment and computer systems.
• Prepares and qualifies e‑batch record & e‑log book.
• Holds knowledge of cleaning validation and process validation.
• Knows project handling with new equipment.
• Familiar with URS, FDS, DQ, HDS, SDS, FS, validation plan, FAT, SAT, IQ, OQ, PQ, validation certificates, PIR, RTM, electronic signature, and electronic reports.
• Knows 21 CFR implementation and automation of pharmaceutical equipment.

• Associate's degree with 4‑6 years of knowledge and experience of GMP documentation required.
• Bachelor's degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or a related discipline from an accredited college/university (preferred).
• Master's degree in Pharmaceutical Engineering, Pharmaceutical Sciences, or related field of study from an accredited college/university (preferred).
• Minimum four (4) years of documentation experience and six (6) years of related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

• Excellent communication skills, drive, and sense of urgency.
• Excellent computer skills, specifically Microsoft Office Suite.
• Solid organizational and time‑management skills to prioritize activities consistently with departmental and sitewide objectives.
• Follows strict internal protocols and SOPs as well as current cGMP, compliance with legal regulations, and environment monitoring.
• Self‑starter who handles multiple priorities in a dynamic, cross‑functional team‑based environment.
• Knowledge…