Process Control Technologist
Job
Actalent
Syracuse, NY (In Person)
$90,000 Salary, Full-Time
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Job Description
Job Title:
Process Control Technologist III / Validation Specialist Job Description We are seeking an experienced Validation Specialist for the position of Process Control Technologist III. The ideal candidate will have extensive experience in equipment, process, and computer/control system validation within a pharmaceutical manufacturing environment. Responsibilities Design, conduct, and report validation studies for equipment and processes, including FAT, SAT, IQ, OQ, PQ, and PPQ. Complete all aspects of the validation process, including design/development, writing validation protocols, executing validation studies, and writing final reports. Coordinate and execute validation studies with production, QA, QC, materials management, and other internal departments. Perform test runs in compliance with protocols and SOPs, completing proper documentation. Compile and analyze data collected during test runs, including creating graphs, charts, or tables as needed. Participate in project teams for new equipment and processes, providing input on validation requirements, resources, and timing. Develop new product and facility validation strategies. Complete validation maintenance, including confirmations, continued process verifications, and periodic revalidation studies. Provide training and guidance to less experienced staff and review their work. Support change control administration, evaluating changes for impact on validations and calibrations. Work with customers, vendors, and external service providers to complete validations. Represent the department at audits and assist in CAPA development and implementation. Essential Skills Bachelor's degree in sciences or equivalent; master's degree is a plus. 5+ years in the pharmaceutical validation field; experience with sterile product/process validation is a plus. Experience administering a change control program in a regulated industry. Exceptional technical writing skills. Knowledge of contemporary validation practices and procedures in a pharmaceutical manufacturing environment. Proficiency in using computer software, including databases, spreadsheets, and word processing. Ability to operate specialized equipment, such as temperature datalogging systems. Understanding of cGMPs, industry standards, and validation guidelines. Attention to detail and ability to manage multiple projects, priorities, and deadlines. Strong communication skills with coworkers and management. Additional Skills & Qualifications Membership in specialized groups and committees, as assigned. Ability to review, edit, and approve SOP revisions ensuring compliance with validations. Work Environment The work schedule is Monday to Friday, from 7:30 AM to 4 PM. Working days and hours may vary based on the production schedule. Job Type & Location This is a Permanent position based out of Syracuse, NY. Pay and Benefits The pay range for this position is $90000.00 - $90000.00/yr. Company Benefits Company Benefits Company Benefits- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Syracuse,NY.
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