manufacturing engineer

manufacturing engineer.

• pennington , new jersey

• posted january 2, 2024

job details

summary

• $54.29 - $76.31 per hour

• contract

• bachelor degree

• category computer and mathematical occupations

• reference1037095

job details

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: $54.29 - 76.31 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities

• 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

• ComplianceEqual 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 ~~~ 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 ~~~ 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.