General Information

Country United States

City Pennsville, New Jersey

Functional Area Operations

Job Group Production

Employment Type Permanent Contract

Working time Full-time

At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.

Your role

SUMMARY: 
The incumbent coordinates with Operations all wet train activities for new/changing production processes.  This may include managing all tasks assigned to Process Engineers or managing the activities directly.

ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
-Manages all projects assigned to the Process Engineering group.
-Oversees all work assigned to Process Engineers and completes performance appraisals.
-Manages the Process Engineering group to support all aspects of the wet-train production campaigns, including: 
-Writes Production documentation: PCLs, BLRs, CLRs, Deviation Investigations
-Requests/recommends equipment modifications 
-Requests/recommends and manpower allocation from Production Management / Supervision to ensure that new/changing processes are adequately staffed.
-Provides start-up support, technical guidance, and trouble-shooting
-Trains production personnel on BLRs, PCLs, CLRs, and validation protocols.
-Writes Post Campaign Summaries for production campaigns, and makes recommendations for future campaigns.
-Assists in GMP compliance.
-Reviews, requests, and/or recommends equipment upgrades for Wet Train Production Buildings to improve operability, cycle time, yield, and safety.
-Oversees the execution of any validation associated with a campaign.
-Reviews production documents.
-Works with interdepartmental groups (i.e QC, QA, EH&S, DEA, Chemical Development, and Engineering) to ensure production meets set deadlines and regulatory requirements.
-Ensures that personal and departmental moral, ethical, legal, and behavioral conduct is in compliance with the Siegfried Code of Conduct.
-Adheres to all applicable cGMP, DEA, and SHE regulations.

SUPERVISION:
The incumbent directly supervises up to 6 Process Engineers and is responsible for all staffing, training and performance management of the direct reports.

Your profile

EDUCATION AND EXPERIENCE:
-MS Degree in Chemical Engineering and 10+ years of experience in process engineering in a batch pharmaceutical industry.
-cGMP experience a must.


OTHER REQUIREMENTS:
-Must have excellent verbal and written communication skills.
-Must be able to work efficiently with people of all levels and cultures.
-Must be very conscientious and detail-oriented.
-Must be a team player.
-Must be a self-starter and initiator.
-Must be able to manage projects and prioritize appropriately.


Siegfried USA will explore and provide reasonable accommodations to assist any qualified individual with a disability in performing the essential functions of his/her job.  Please speak with HR should you require an accommodation or have any questions.

Working at Siegfried

Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.

Who we are

In the Midst of People’s Lives – Across the Globe

The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model. 

The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production. 

We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.

What we do in Pennsville

Pennsville is our drug substance manufacturing site for the US mar-ket and provides spray drying operations globally.

Main activities

  • Pilot and commercial manufacturing of drug substances (APIs) and related intermediates
  • All fully cGMP and SHE compliant

Features

  • 3 GMP pilot suites: 0.1–2 m³ reactors
  • 200m3 commercial capacity: 1–10 m³ reactors
  • Successful transfer of new products to the commercial scale - Powerful rectification
  • Spray drying in pilot and commercial scale for both isolation and dispersion technology
  • Micronization in pilot and commercial

Strategic importance

  • CMO for innovative drug substances and manufacturer of our opiates portfolio for the US market