PCI Pharma Services · 1 day ago
VALIDATION ENGINEER I
Bedford, NH, USA
Full-time
Onsite
Entry Level
1+ years expPCI Pharma Services is a global leader in providing life-changing therapies and is seeking a Validation Engineer I to support validation activities in cGMP pharmaceutical and medical device contract manufacturing. The role involves executing validation protocols, assisting with test protocols, and collaborating with cross-functional teams to ensure compliance with validation requirements.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Perform administrative activities such as data entry into Validation scheduling tools, scan validation documents, and file validation documents
Execute Test Protocols, including identification and resolution of non-conformances/deviations
Assist with test protocols for installation, operation, performance of equipment, and IQ/OQ/PQ
Under the direction of senior level validation engineers and manager execute validation related activities IQ/OQ/PQ for (Facilities, equipment, utilities, processes, and materials)
Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to schedule validation deliverables
Coordinate and work on Validation deviations and participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA)
Collaborate and propose corrective actions to validation manager to implement the required changes
Qualification
Required
Experience in pharmaceutical or biopharmaceutical environment in operations/engineering/manufacturing/quality environments
Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred
Associate/Bachelor's degree in Engineering or related scientific discipline with 1-3 years of Pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, or Engineering
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities
Possess functional knowledge of commissioning, qualification validation, practices, including applicable regulations
Strong technical writing, verbal communication and presentation skills
Proficiency in Microsoft Office including Word, Excel, Power Point, Project
Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment
Professional and collaborative team player must have strong interpersonal skills
Honesty, integrity, respect and courtesy with all colleagues
Self-motivated and able to meet goals following the input and guidance of management as well as from more experienced Validation Engineering team members
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services 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
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase