Almac Group · 12 hours ago
Validation Specialist
Audubon, PA
Full-time
Onsite
Entry Level
1+ years expAlmac Group is a leading drug development solutions provider in the pharmaceutical industry, currently seeking a Technical Quality Officer. The role involves managing validation activities to ensure compliance with regulatory requirements and industry standards, including overseeing the validation life-cycle and liaising with various stakeholders.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
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 re-qualification and periodic review schedules
Qualification
Required
Bachelor's Degree
1 year experience in a technical or scientific environment or internship in technical or scientific area
Preferred
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
Benefits
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 as well as one day for Annual Diversity Day
Company paid Long and Short-term disability along with Life Insurance
401k company contribution
Professional development programs/ continuous learning opportunities
Company
Almac Group
Almac Group is a contract development and manufacturing firm offering integrated services to pharmaceutical and biotech companies globally.
5001-10000 employees
H1B Sponsorship
Almac Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2021 (1)
Funding
Current Stage
Late StageTotal Funding
$1MKey Investors
Bill & Melinda Gates Foundation
2019-12-04Grant· $1M
Leadership Team
Alan Armstrong
Chairman and CEO
Gerald Donnelly
Analyst
Recent News
2025-10-20
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2025-08-15
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