Manufacturing Engineer

Job Title:
Manufacturing 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

Job Description

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.

The job duties for this position include but are not limited to the following:

• Develop appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on an agreed frequency
• Creates training materials for subject matter input.
• Track and manage periodic review.
• Develop 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.
• Lead and/or support root cause investigations related to performance trends and formal deviations.
• Develop, implement and assess 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 Master Control database by assuring new documents have been entered using appropriate protocols.
• Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
• Performs other duties as assigned.
• Knowledge of qualification and validation documents.
• Preparation of qualification and validation documents of equipment and computer system.
• Preparation and qualification of e-batch record & e-Log Book.
• Knowledge of cleaning validation and process validation.
• Knowledge in project handle with new equipment.
• Knowledge of URS, FDS, DQ, HDS, SDS, FS, validation plan, FAT, SAT, IQ, OQ, PQ, validation certificate, PIR, RTM, electronic signature, electronic reports.
• Knowledge of 21 CFR and implementation. Knowledge of automation of pharmaceutical equipment.

Education and Experience

• Associate’s degree with 4-6 years knowledge and experience of GMP documentation required.
• Bachelor’s degree in science, biochemistry, pharmaceutical engineering, Pharmaceutical Sciences, or 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 documentation experience and six (6) years related pharmaceutical or biotech industry experience. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Technical Knowledge and Computer Systems Skills

• Excellent communication skills, drive, and sense of urgency
• Excellent computer skills, specifically Microsoft Office Suite.
• Solid organizational and time management skills are required to prioritize activities in a manner consistent with departmental and site wide objectives.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
• Must have ability to work as a self-starter and handle multiple priorities in a dynamic cross-functional team-based environment.
• Knowledge of pharmaceutical manufacturing and related documents.
• Knowledge and experience writing, revising and creating cGMP records and SOPs.
• Knowledge of GDP.
• Creation and maintenance of batch record and cGMP documentation templates.
• Hands‑on experience facilitating problem…