Job description

1. Role Purpose:

The Technical Services Associate ensures process equipment systems consistency and effectively perform for the overall manufacturing operations team, by providing expertise for standardizing and improving existing processes, R&D batches, product launches, CAPA, and support of production operations. The Technical Services Associate will work with cross-functional departments, manufacturing equipment, material suppliers, all to ensure that the technical needs of Manufacturing are being met on a consistent basis and ultimately ensuring robust, compliant, and efficient manufacturing processes are in place with respect to processing equipment and/or component interaction. Position focus will be on facility/production line start-up and new product introduction/transfers.

2. Key Duties & Responsibilities:

• Assist with supporting Manufacturing and/or Quality troubleshooting day-to-day operations, pipeline products in aseptic manufacturing processes, and capital projects
• Assist with troubleshooting and optimization aseptic manufacturing processes and related operations
• Assist with developing specifications for the procurement of process equipment and components
• Write the production batch record
• Assist with the transfer of new product from R&D to manufacturing
• Technical specialist with equipment and components (e.g., vials, seals, stoppers, etc.) in optimizing component performance and/or processing equipment compatibility with goal to minimize reject rates
• Assist manufacturing on validation protocol development and execution for process and related equipment
• Assist with the development & completion of risk assessment as it relates to processes, equipment, product quality
• As needed, support equipment startup and commissioning of process and facilities
• Support deviations and investigations with technical research, study assessments, and data analysis
• Implement process design improvements that prevent batch loss, improve yields, and reduce costs
• Support change control evaluation with evidence-based data that justifies and/or proves effectiveness
• Perform technical review of batch record eliciting execution performance data for analysis and improvement
• Monitor and manage process equipment performance. Identify issues, improvements, and implement.

3. Education & Experience:

Bachelor’s Degree in Technical or related field preferred

5 years of relevant experience in an aseptic filling environment. BS in mechanical engineering a plus. Equipment design experience a plus.

Experience in process development, process optimization, and scale-up of sterile liquid products preferred

Experience in new product introduction, technology transfer, and process/equipment validation preferred

4. Technical competencies/ Certifications/ Licenses:

• Applied experience in bulk and finished product primary components (i.e. product contact) of caps, seals, vials, bulk containers. Packaging component experience a plus.
• Working knowledge of various manufacturing processes and unit operations including, equipment/component preparation liquid bulk compounding, vial filling, formulation, & secondary packaging
• Good knowledge of process automation/control systems 21CFR Part 11 requirements
• Applied understanding of cGMPs and FDA & EMA biopharmaceutical regulations and industry standards (e.g. classified zones, aseptic techniques, sterile boundary concepts, packaging serialization)
• Excellent oral and written English communication. Ability to demonstrate proficiency
• Continuous improvement with knowledge of Lean Manufacturing/Six Sigma tools/techniques desirable

5. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Job Type: Full-time

Pay: From $50,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Newtown, PA 18940: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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