Process Implementation Specialist

Corden Pharma

is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people's lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

Include the following. Other duties may be assigned.

• Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and CPC customers related to assigned products
• Executes all startup activities for chemical process in their area to ensure schedule adherence
• Assists Technical Team with defining process equipment and process training
• Generates change control documents, process and equipment design reviews, updates drawings and P&IDs, and completes change control closure
• Works with Maintenance and Operations to ensure all maintenance activities are scheduled and completed
• Assists Technical Team to ensure cleaning development can be performed effectively and efficiently
• Generates Cleaning Procedures and Cleaning Protocols. Provides training and guidance to Operations on the cleaning/changeover plans and priorities
• Assists with the generation of qualification documents to ensure effective and efficient execution
• Ensures the plant or process areas have the necessary equipment to perform changeovers and operations. Procures equipment and supplies as needed
• Communicates with peers and management to ensure that priorities are adequately defined and coordinated
• Assists with investigation into deviations and implements resulting CAPAs
• Participates in process and equipment PHAs
• Executes roll-out of manufacturing processes to the appropriate plant
• Represents Manufacturing for project design work and implementation to ensure new systems meet operational requirements regarding EH&S and efficient operations, while meeting budgetary requirements
• Ensures that documentation is issued in a timely fashion and is completed within acceptable timelines. This includes change control, cleaning documents, training information, safety procedures shutdowns, project preparations, and specialized operating procedures (as needed)
• Implements and maintains adherence to all company policies concerning Environmental, Health & Safety;
  Quality; and Human Resources

Acts as a single point of contact for implementation of a process in the manufacturing areas.

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor's degree (BS) from a 4-year college; or 5 years related experience in Chemical or Pharmaceutical Manufacturing (GMP preferred) and/or training; or equivalent combination of education and experience.

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information, and respond to questions from groups of managers, clients, customers, and the public.

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution; determination of test reliability and validity; analysis of variance; correlation techniques; sampling theory; and factor analysis; etc.

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.