Validation Specialist

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.

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.

Bachelor's Degree in scientific or engineering discipline

3+ years experience working in a cGMP environment

Experience with packaging equipment: blistering equipment, bottling, carding, labeling,

pouching, autoinjector and/or syringe assembly preferred.

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

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

Risk Assessment and Management

Data Integrity regulations

* 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

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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 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 ADARequest@almacgroup.com to request assistance.