Senior Validation Specialist -- Temp

SR. SPECIALIST, VALIDATION

COMPANY OVERVIEW

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada.

Our family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is now part of Noramco. We are stronger together!

100% onsite position at 30 N. Jefferson Rd, Whippany, NJ

POSITION SUMMARY

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.

REQUIRED QUALIFICATIONS

• Bachelor’s degree in engineering, Life Sciences, or related STEM discipline.
• Minimum 5 years of validation experience in the pharmaceutical or biopharmaceutical industry, specifically in manufacturing and packaging.
• Experience with validation of:
• 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.

PREFERRED QUALIFICATIONS

• Master’s degree or higher in a relevant field.
• Experience with Cleaning Validation.
• Familiarity with developing / designing validation project.
• Prior client-facing experience supporting tech transfers or product launches is highly desirable.

PHYSICAL & TRAVEL REQUIREMENTS

• Must be physically capable of working onsite in a GMP environment.
• May require use of personal protective equipment (PPE).
• Occasional travel to support offsite activities may be required.

OSITION SUMMARY

Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background

Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Job Type: Temporary

Pay: $45.00 per hour

Work Location: In person