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

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 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 solving and root cause investigations in a pharmaceutical environment - Develops, implements, and assesses solutions for complex problems.
• Ability to work effectively both independently and as part of a team.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.
• Knowledge and handling of deviation, CAPA, change control, FMECA and training.
• Knowledge and handling of SAP system, master control and Track wise system.
• During audit part of team.
• Knowledge of audits and compliance.

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’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 at InvaGen Pharmaceuticals, Inc, Fall River, MA.

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

• Develops appropriate disposition metrics, works with manufacturing/packaging personnel to achieve said targets. Generates and reports on metrics on 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 document 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.