Process Implementation Specialist

Corden Pharma Colorado

11d

About The Position

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

Requirements

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.
Ability to work chemical process areas as assigned
Excellent understanding of Chemical or Pharmaceutical Manufacturing
Results oriented approach to process performance
Strong leadership, delegation, verbal, and written communication skills
Ability to build relationships and influence and motivate others
Ability to achieve results through the positive direction of others
Technical expertise in the practices and technologies used in assigned manufacturing area; and the ability to use these skills in active projects
Basic knowledge of Chemical Processing, Plant Equipment, and Infrastructure
Analytical problem-solving skills, including the execution of LEAN Operational Excellence Systems where applicable
Familiarity with investigation and incident/deviation response tools (e.g., 6M, 5 Whys, Fishbone), CAPA Management, and team-based problem resolution
Working knowledge of regulatory compliance issues in pharmaceutical manufacturing
Planning, implementation, and follow-up skills

Responsibilities

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

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance