VALIDATION SPECIALIST Job Opening in Wayne, NJ

Assures operational compliance to cGMPs as well as SOPs and customer-required protocols in accordance with CFR 21, Part 11, 210, & 211 during packaging processes. The Validation Specialist is responsible for facilitating and coordinating all activities of the Validation Department . The activities must support continuous compliance of all regulatory and company rules.

Responsibilities:

Includes but is not limited to:

• Develop, implement and update the Master Validation Plan for the packaging facility.
• Establish, document and manage the Bioburden Monitoring Program.
• Develops and documents change controls, validation plans, qualification protocols, associated reports and documents.
• Maintain and update a documented Cleaning Validation program.
• Maintain Validation Documentation/Control Plan.
• Reviews and updates Standard Operating Procedures applicable to this job function.
• Schedule, conduct and document External audits.
• Coordinate all validation processes regarding validation programs and schedule with Customers.
• Coordinate with all RL departments.
• Review change controls for equipment and validation impact.
• Reviews and approves calibration, qualification and validation documentation for accuracy, completeness and compliance

Will assist in the following areas when needed:

• Assists in the preparation and execution of Deviations, Complaints and Non-conformance Investigations.
• Reviews and Updates Standard Operating Procedures applicable to this job function.

Qualifications:

· Able to work independently and as part of the team.

· Exceptional communication (written and verbal) interpersonal skills.

· Maintains a high level of multi-tasking ability in conjunction with proven organizational skills.

· Computer (PC), data collection, and analysis skills necessary to fulfill job responsibilities.

· Able to comprehend packaging equipment concepts for Validation purposes.

· Detail orientation a must.

· Minimum 5 years pharmaceutical experience or equivalent.

· Must have command of the English Language, both written and verbal.

· Proven abilities in the development, execution and final review of IQ/OQ/PQ-PV validation protocols.

· Experienced in development, execution and final review of calibration requirements with contracted providers.

· Ability to communicate effectively with customers regarding all aspects of validation and calibration.

Physical Demands

· The person in this position is required to move about inside the office, to file cabinets, office machinery.

· The person in this position is required to communicate to employees in all position levels. He/she must be able to exchange accurate information in these circumstances.

· This person must be able to travel via air and ground for periods of time required to perform supplier audits.

· This person must be able to stay in a stationary position up to 80 % of the time.

· This person must be able to lift and transport boxes and/or totes up to 25 pounds.

Training:

New hires or transfers into this position shall be given a three-month trial orientation period in order to become proficient. Proficiency shall be evaluated by the area manager or trainer and become part of the employee’s training record.

Job Type: Full-time

Pay: $65,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program

Schedule:

• 8 hour shift
• Overtime

Ability to commute/relocate:

• Wayne, NJ 07470: Reliably commute or planning to relocate before starting work (Required)