Overview: The Senior Validation Engineer will be responsible for the preparation, review, and approval of quality and validation related documentation and ensuring compliance during manufacturing operations. Ensures implementation of latest applicable regulatory trends for data integrity/security using tools and procedures that will enforce compliance to these requirements across the organization.

Responsible for Cleaning Validation Protocol Development: Lead the development, review, and approval of cleaning validation protocols, master plans, and associated documents to ensure compliance with regulatory requirements and internal quality standards. This position reports to the Quality Assurance IT Manager.

Responsibilities

• The Sr. Validation Engineer leads and performs Commissioning, Qualification, and Validation (CQV) activities in support of cGMP manufacturing, fill finish, and QC laboratories. Responsible for preparing appropriate documentation for assigned projects in the areas of equipment, software, process, control system and critical system C & Q and validation activities.
• Responsibilities associated with this position include maintaining qualified state of cleaning processes and procedures as well as design and implementation of new cleaning processes. The candidate must be well organized and technically sound in understanding of cleaning validation principles including development of acceptance criteria, within a pharmaceutical or medical device manufacturing environment.
• Additionally responsible to work closely and oversee the CSV validated state for American Injectable’s GxP Computer Systems based on industry best practices, cGMP, GAMP5, and 21CFR11 requirements.
• Ensures implementation of latest applicable regulatory trends for data integrity/security using tools and procedures that will enforce compliance to these requirements across the organization.
• Project management and support of validation and quality system projects.
• Utilize risk assessment to identify critical areas for validation and generate test scripts accordingly.
• Review change control documents, work orders, document change requests for assessing impact on validated systems. Identify process improvement opportunities and equipment needs for manufacturing / packaging.
• Establish and maintain good practices with regards to processes and /or internal conditions leading to an aseptic environment.
• Demonstrate superior project management skills and leadership qualities.
• Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
• Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
• Support Agency, customer, and vendor audits as needed.
• Resolves protocol discrepancies and deviations and provides inputs to complex technical issues.
• Reviews vendor-generated validation protocol packages
• Supports change control deliverables
• Responsible for the generation of complex protocols using a risk-based approach that meets current regulatory requirements and industry practices

Qualifications

Required Skills/Abilities:

• Strong technical writing including protocol generation, deviation investigation and generation as well as report writing is required. The candidate must be a team player, who thrives in a team environment, but also has the ability to work on their own.
• Must be proficient in Technical writing.
• Must have direct experience developing, executing and generating validation reports for pharmaceutical manufacturing and laboratory equipment, including hands on experience with cleaning validation.
• Requires a thorough understanding of 21 CFR Part 11, EU Eudralex Vol 4 Annex 11, ICH Q9/10 requirements and ASTM E2500, GAMP 5 principals, and any other industry specific pharma provisions as they apply to systems management and deployment.
• Hands on Cleaning Validation experience required. Hands on CSV experience preferred.

Education/Experience:

• Minimum of 10 years of experience worked as a Validation Engineer.
• BS/MS Biology/Chemical/Biochemistry/Biomedical/ Mechanical/ Industrial Engineering.

Physical Requirements:

• Employee may be required to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.

Training:

• Must successfully complete all departmental training modules and meet the requirements as part of ongoing training.
• Must successfully complete all material handling training/verification as part of ongoing training.

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 10 years

Work setting:

• In-person