Job Title: Lab Tech II

Job Description

The Process Development Tech II position involves processing human, porcine, and fat-based tissue products. This role requires clean room gowning and working in a lab setting. The Process Development Tech II ensures the continuous flow of processing activities and serves as a subject matter expert. The position involves various physical activities including lifting up to 30 pounds, sitting, walking, and operating equipment. Attention to detail is crucial when testing and processing tissue samples. The role also requires comprehension of work instructions and safety requirements, as well as the ability to work with solvents, cleaners, and disinfecting products in different environments.

Responsibilities

• Precisely follow company tissue requests, study designs, protocols, and SOPs for processing tissue-based products.
• Perform lab testing to verify and validate product/device functionality.
• Assist in developing processes for manufacturing and commercial tissue products.
• Work with the in-house manufacturing group to scale-up, validate, and transfer the commercial manufacturing process.
• Monitor process and equipment performance and make recommendations for continuous improvement.
• Serve as a subject matter expert and provide guidance to junior staff.
• Train new employees.
• Operate heat sealers, biohazard laminar flow hoods, aspiration systems, weighing scales, orbital shakers, splitters, grinders, gerber tables, and mixers.
• Record information on batch records, equipment and cleaning logs, and other documents.
• Maintain inventory of processing supplies.
• Use computers to enter data and generate reports.

Essential Skills

• Associate’s degree with 3-5 years of experience.
• Excellent interpersonal skills to effectively participate with project teams.
• Understanding of Quality System Regulations (QSR).
• Ability to lift 25 pounds.
• Prior experience with using manufacturing equipment for the medical device industry.
• Prior experience in the development of tissue-based products.
• Prior experience in aseptic processes.
• Understanding of GDP and GMP.
• 5 years of experience in a cGMPs, GDP, ISO, FDA regulated industry.
• Advanced computer skills and high knowledge of Windows-based computer systems.
• Knowledge of cGMPs, AATB Standards, ISO, FDA, and USP regulatory guidelines.
• Experience with SAP (ERP).
• Basic knowledge of statistical techniques and quality tools.

Additional Skills & Qualifications

• Quality/R&D experience.

Work Environment

The Process Lab Environment involves working with industrial machinery and processing at a higher level. The environment is regulated by cGMPs, GDP, ISO, and FDA standards. The position follows a first shift schedule with flexibility (7am-3:30pm).

Pay and Benefits

The pay range for this position is $22.00 - $23.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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 Branchburg,NJ.

Application Deadline

This position is anticipated to close on Feb 17, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $22 - $23