Job Title: Sr. Validation Specialist

Job Description

We are seeking a highly skilled Sr. Validation Specialist to develop validation protocols, execute pre-approved test cases, and prepare summary reports. The successful candidate will act as a validation representative on assigned projects, attend project meetings, and perform peer reviews of executed protocols and data generated by other specialists in the department. The role also involves acting as a subject matter expert on validation of sterilization processes and aseptic process simulation requirements, coordinating support from other departments, and reviewing validation procedures and policies as needed.

Responsibilities

• Develop and execute validation protocols.
• Prepare summary reports for validation tasks.
• Attend project meetings as scheduled by others.
• Perform peer reviews of executed protocols and data.
• Act as a subject matter expert on validation of sterilization processes such as autoclave cycles, SIP, dry heat dehydrogenation, and VHP decontamination.
• Act as a subject matter expert on aseptic process simulation requirements.
• Coordinate support from QC laboratories and production personnel to complete validation tasks.
• Review and update validation procedures and policies as needed.

Essential Skills

• 5 years of experience in one or more of the following areas: validation of aseptic process simulations, steam sterilization, isolators and decontamination cycles with VHP, cleaning validation, manufacturing of sterile injectable products, environmental monitoring performance qualification, and air visualization/profile studies.
• Bachelor's degree in engineering, chemistry, or microbiology.
• Knowledge of 21 CFR Part 211 and experience with FDA inspections.
• Knowledge of Eudralex Annex 1 (current version).
• Proficiency in Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMP).
• Excellent written and verbal communication skills.
• Excellent organizational and leadership skills.
• Proficiency with spreadsheets and databases.
• Ability to use a respirator.
• Ability to work with microorganisms and hot liquids.

Additional Skills & Qualifications

• Experience in microbiological assays and testing.
• Desired experience in environmental monitoring and trending.
• Desired experience in the testing of utilities.

Work Environment

This role interacts with Microbiology management routinely, with some interaction with manufacturing, validation, QC, and QA personnel. It also involves routine interactions with vendors. The typical work schedule is 8 AM to 5 PM, Monday to Friday, with a 40-hour workweek. Additional working hours, extended shifts, or weekends may be required based on business needs. The position is based in a pharmaceutical lab with a cleanroom, in a team-oriented environment.

Pay and Benefits

The pay range for this position is $65.00 - $75.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Birmingham,AL.

Application Deadline

This position will be accepting applications until Jan 25, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $65 - $75