Almac Group is currently seeking a Validation Specialist for our Audubon, PA location. The Validation Specialist is responsible for managing validation activities within Almac pharma services to ensure that all critical facilities, utilities, systems and processes remain in compliance with applicable regulatory requirements and industry standards.
Responsibilities include but are not limited to:
- Actively manage and be involved in the execution of all stages of the validation life-cycle including:
- Development of project design documentation.
- Generating validation plans for larger projects.
- Planning, preparation and execution of equipment and process validation protocols and reports in support of the site’s validation program.
- Planning, preparation and execution of cleaning validation of clean-in-place systems, packaging equipment and production facilities.
- Performing risk assessment and gap analysis for site cleaning programs and validation requirements.
- Performing periodic review of cleaning validation studies.
- Liaison with non-Pharma Services personnel (including manufacturers, suppliers, clients and external validation/qualification resources).
- Compilation of validation protocols and reports.
- Collation and analysis of process validation data.
- Witnessing of certain validation activities.
- Manage and complete the periodic re-evaluation and requalification of equipment and systems, as determined by the schedule.
Qualifications:
Required Experience / Education:
- Bachelors Degree
- 3+ years of experience in working in a cGMP environment.
- 3+ years relevant experience in equipment, process and cleaning validation
- Knowledge of the regulatory requirements and industry standards for validation of pharmaceutical packaging equipment, process and cleaning processes
Preferred Experience / Education:
- Bachelors Degree in Chemistry
- Proficient knowledge of cleaning validation and continuous process improvement in the pharmaceutical industry.
- Knowledge of Risk Assessment and Management.
What Almac Group can offer YOU!
- Full medical, vision & dental benefits the 1st of the month after start date
- 20 days of PTO to start plus 12 holidays per year
- Company paid long and short term disability along with life insurance
- 401k company match
- Professional development programs/ continuous learning opportunities
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Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing almost 7,000 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. ‘Partnering to Advance Human Health’ is more than just a tagline – it is our way of life.
Embracing diversity is at the heart of enhancing Almac Group’s unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally.
RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV’s not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.
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Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.