- Draft, review, and approve qualification protocols/reports and related documentation for equipment, utilities, and facilities.
- Drive validation activity closure for a new facility.
- Assist in developing, reviewing, and approving cGMP documents including Master Validation Plans, FAT/SAT documents, SOPs, specifications, traceability matrices, thermal mapping documents, and design documentation.
- Provide expertise and solutions concerning CQV Lifecycle documentation complying with FDA/EMEA Regulations.
- Support validation activities for project activities and attend validation activities, reviewing validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ).
- Enforce CQV guidelines, policies, and procedures for equipment, analytical equipment, utilities, and facilities.
- Collaborate closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
- Ensure appropriate investigation and resolution of validation discrepancies, errors, or protocol failures.
- Perform other duties across departments as requested and explained by the Manager. Requirements:
- Scientific degree (pharmaceutical sciences, engineering, chemistry, or related discipline).
- 5+ years' validation, biological quality assurance, or quality control experience in an FDA-regulated biotech or pharma company.
- 1-3 years in a quality assurance or quality control role in an FDA-regulated company.
- strong knowledge of cGMPs, 21CFR parts 2010 & 211, and preferably 21CFR600 - Biologics.
- Familiarity with ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
- Proficient in risk assessments and documented, risk-based approaches.
- Proven track record in a similar position with good project management skills.
- Excellent communication, analytical, and problem-solving abilities.
- Hands-on approach, able to work autonomously with minimal supervision.
- strong attention to detail and ability to work accurately in a busy environment.
- Self-motivated, proactive, and committed to learning and development.
- Highly desirable: Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook).
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills: - Manufacturing
- Validation
- Compliance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled. -
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Manufacturing Engineer - Pennington, United States - Randstad USA
Description
job summary:A Manufacturing Engineer is needed for a global biotechnology company known for discovering and developing innovative oncology medicines in the Hopewell, NJ area. This job oversees validation compliance, drives procedures, and ensures quality assurance in an FDA-regulated environment.
location: Pennington, New Jersey
job type: Contract
salary: $ per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
