Validation Manager (Relocate to Illinois, USA)

Position Title : Validation Manager

Department : Validation

Work Location : Decatur, Illinois

Position Summary :

The Validation Manager will provide expertise, guidance, and oversight for the Validation efforts at the Rising Facility.

This role involves ensuring the development and implementation of the Rising Validation Department and the Site Validation Master Plan.

The Validation Manager will oversee industry "best practices" using resources such as ISPE and PDA, continuously upgrading the site's validation practices and procedures.

The position also involves managing site compliance with current FDA regulatory requirements and working with all levels of management, staff, and internal departments, including outside contractors and vendors, as applicable.

Essential Duties & Responsibilities :

• Provide expertise in the development, execution, and review of validation protocols.
• Develop and maintain a requalification schedule for facilities, equipment, and processes based on risk assessments, current industry "best practices," and regulatory requirements.
• Schedule staff to meet aggressive validation timelines.
• Maintain and implement the Rising Validation Master Plan Schedules, including facility, equipment, and process requalifications.
• Demonstrate excellent working knowledge of cGMP requirements on validation methods and principles, including ISPE, GAMP guidelines, and FDA CFR Part 11 Electronic Records and Signatures requirements.
• Hire, mentor, and train staff and other resources as needed.
• Develop and write applicable validation documentation, including URSs, FDSs, DOEs, FATs, IQs, OQs, PQs, and VQs from scratch / manuals if not readily available.
• Handle multiple, complex projects and work independently.

Additional Responsibilities :

Perform other duties as assigned.

Education and Experience :

• Bachelor’s Degree from a four-year accredited college or university with a major in Engineering, Chemistry, or Microbiology, with a preference for the Engineering Sciences or ten (10) years’ experience in the pharmaceutical industry.
• Minimum of five (5) years management experience in a leadership role.
• Certified Engineer or CQE is a plus.
• Sterile injectable experience required.

Job Prerequisites :

• Must be mentally flexible in dealing with difficult situations.
• Must understand vague and implicit instructions and react favorably in complex situations.
• Excellent communication, writing, and computer skills.
• Ability to meet attendance standards. All full-time employees are required to work a 40-hour week, most of which has to be during "regular" business hours.

At times, it may be necessary to work additional hours to get the required tasks accomplished to meet deadlines.

• Ability to operate and troubleshoot validation monitoring equipment.
• Ability to estimate and maintain project timelines.
• Fully knowledgeable with computerized systems and programs.

Physical Demands, Mental Requirements, and Work Environment :

Physical Demands :

• Regularly required to sit, stand, walk, talk, and hear.
• Required to use hands to finger, handle, or feel.
• Specific vision abilities required by this job include close vision for written work and PC use.

Mental Requirements :

• Ability to apply deductive reasoning and understand complicated issues.
• Ability to provide instructions and follow up on work rules including company policies.
• Ability to ensure safety and security practices.
• Ability to meet deadlines and effectively deal with office stress.
• Ability to accurately communicate ideas, facts, and technical information.
• Maintain confidentiality of certain information.

Benefits :

• Full benefit package offered : medical, dental, vision insurance, STD / LTD, 100% match to 401K up to 4%, PTO, 8 paid holidays, health savings plans, life insurance, and more.
• Relocation expenses : Case-by-case basis; details / requests need to be reviewed before making commitments.
• Compensation includes bonus and relocation assistance.

If you are a dedicated professional with a strong background in validation and a commitment to excellence, we encourage you to apply for this exciting opportunity.