SR. SPECIALIST, VALIDATION

Job Details Scientific

SR. SPECIALIST, VALIDATION

Whippany, NJ Job Description Job ID#: 119416

Category:

Scientific Job Type:

Temporary Branch:

Parsippany Salary:

$ 45.00 - $ 45.00

Phone:

(973) 299-9920 A contract development and manufacturing organization that specializes in producing topical, semi-solid, and liquid pharmaceutical products for both prescription and over-the-counter markets. It supports clients through formulation, scale-up, manufacturing, and packaging, with a strong focus on quality, regulatory compliance, and speed to market. The Senior Specialist, Validation will lead and execute validation activities across manufacturing and packaging processes for OSD, Liquid non-sterile dosage form. This individual will ensure that all validation activities meet current industry standards, regulatory requirements (FDA, EMA, Annex 1), and internal quality expectations. The ideal candidate will demonstrate strong technical expertise, project leadership, and collaboration within cross-functional teams.

ESSENTIAL FUNCTIONS

• Develop and execute validation project plan, validation protocols for manufacturing and packaging process units.
• Review and analyze product development reports. Conduct risk assessments to determine critical process parameters and validation requirements.
• Manage and lead validation projects, including handling change controls, shop floor support and training on protocols, post validation changes, audit preparation for clients and regulatory agencies.
• Analyze data, write validation reports, and ensure timely approval and closure of validation documentation.
• Review and approve protocols, SOPs, change controls, CAPAs, and technical reports.
• Act as SME during audits (regulatory, client, internal) and support the preparation and defense of validation-related topics.
• Collaborate with Quality Assurance, Engineering, Operations, Analytical Development/ Quality control, Project Management and client to ensure compliant and efficient validation execution in timely manner.
• Ensure alignment with

GAMP5, ISPE

Baseline Guides, FDA Process Validation Guidance, and EU Annex 1.

• Provide mentorship and technical guidance to junior validation engineers and specialists.
• Develop and execute ancillary studies to support product compliance and capability such as holding studies and shipping studies.
• Responsibilities also include performing technical failure analysis of processes/products not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product/process variability.
• Stay updated on industry trends and regulatory expectations; propose improvements to the validation program accordingly.
• May lead or support investigations and root cause analysis related to deviations or non-conformances on validated systems.

Pay rate $45.00/hr Job Requirements

REQUIRED QUALIFICATIONS

Must have a Bachelor"s degree in engineering, Life Sciences, or related STEM discipline. Must have Minimum 5 years of validation experience in the pharmaceutical or biopharmaceutical industry, specifically in manufacturing and packaging.

• Experience with validation of: o Blending, Compression/ En-capsulation, Coating, Roller-compaction, Granulation, Liquid mixing, filling and packaging (Stick pack- powder and granules, tablets/ capsules, liquid).
• In-depth knowledge of cGMP regulations, Annex 1, FDA Guidance, and validation of lifecycle requirements.
• Excellent communication skills to articulate technical information clearly in a GMP environment.
• Proficient in Microsoft Office (Word, Excel, Outlook); experience with validation tools/software preferred like JMP statistical computer software.
• Ability to manage multiple projects simultaneously and meet tight deadlines in a fast-paced environment.
• Available to work off-hours and weekends to support critical manufacturing and validation timelines.
• Experience with Cleaning Validation.

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