Validation specialist

Reference #: 8a7887ac9881bbc601988b55df617482

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. 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. Support the Validations and Quality teams with onboarding of new projects and assets. Responsible for coordination of project activities, timelines and schedules. Work with clients and Project Management teams to understand client and project requirements and development of project specific tasks and timelines. Manage and complete the periodic re-evaluation and requalification of equipment and systems (Production and Laboratory) as determined by requalification and periodic review schedules.

Qualifications:

Required Experience / Education:

Bachelor's Degree 1 year experience in a technical or scientific environment or internship in technical or scientific area

Preferred Experience:

Contract packaging experience Continuous Improvement Capitol Facility projects and/or Ultra Low temperature packaging processes Serialization systems, preferably Optel systems Temperature mapping Proof of concept process mapping for temperature-controlled products Experience with packaging equipment: blistering equipment, bottling, carding, labeling, pouching, autoinjector and/or syringe assembly preferred. 3+ years' experience working in a cGMP environment

Required Knowledge:

Knowledge of the regulatory requirements and industry standards for validation of pharmaceutical packaging equipment, processes and cleaning. Thorough knowledge of and proven experience in validation or engineering role within the clinical, pharmaceutical, or R&D environment

Preferred Knowledge:

Risk Assessment and Management Data Integrity regulations

What can Almac Group offer you?

Medical, Vision & Dental benefits from the 1st of the month following start date 20 days PTO per year, accrued monthly following start date 12 holidays per year Company paid Long and Short-term disability along with Life Insurance 401k company contribution Hybrid work available for applicable roles *Professional development programs/ continuous learning opportunities Want to see our latest job opportunities? Follow us on Linkedin

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 6,000 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. EEO is the Law EEO is the Law GINA Supplement Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.