The Process Engineer is responsible for all aspects of PharmaChem Technologies G.B. LTD. Process Engineering support to include: assessing, designing, altering, qualifying and trending Process Engineering systems in support of day-to-day manufacturing.
Additionally, the Process Engineer is responsible for supporting PharmaChem Technologies G.B. LTD. Process and Plant Engineering systems during the design, construction, qualification, alteration and maintenance of new and existing equipment and systems; to ensure compliance to cGMP’s, SAFETY, good Engineering practices and applicable codes and standards.
The Process Engineer reports to the Senior Process Engineer.
DUTIES AND RESPONSIBILITIES
The Process Engineer:
- Collects and maintains data on process execution and equipment performance, using this to define needed process changes and equipment modifications.
- Serves as the Engineer responsible for and in charge during the design and installation of Process, Mechanical, Environmental and Piping based systems. This includes the development or approval of design documentation, e.g. Functional Requirements, Functional Specifications, Design Specifications, Datasheets, PFD’s, P&ID’s, M&E Balances and Waste Summaries, etc.
- Provides engineering support as needed for Process, Mechanical, Piping, Environmental and Utilities systems. Reviews design, qualification, change control, procedural and other related Site Facility Documents and advises on technical matters involving the previously mentioned systems.
- Develops and administers site hard copy and electronic documentation on Equipment, Utilities and Facilities, including Drawing Files, Equipment Files, Project Files and Site Lists.
- Supports the development of the Process Engineering expense and capital budgets and supports the development and execution of capital and expense budgeting process for the Engineering department and the site as a whole.
- Supports the execution of Capital and Non-Capital Projects during the Scope, Design, Construction and Qualification phases. Initiates CARs on approved projects. Acts as Process Engineer, Project Engineer, Project Leader or Project Manager on assigned Capital and Non-Capital Projects.
- Oversees on behalf of PharmaChem Technologies G.B. LTD., Mechanical and (where required) Process Consultants, Contractors and Vendors, as required, and maintains records on transactions with them.
- Ensures that site Engineering Activities adhere to appropriate cGMP, Safety and other regulatory standards.
- Performs other tasks as directed by the Senior Process Engineer.
EDUCATION AND QUALIFICATIONS
The Process Engineer must have completed:
A Bachelors Degree in Chemical Engineering or Engineering Technology (Major in Chemistry) from an accredited College or University; along with 5 yrs of demonstrated experience in the industrial field as a Project/Process Engineer.
SKILLS AND SPECIFICATIONS
- The Process Engineer must be an excellent communicator and planner, capable of expressing specific plans, objectives and performance criteria to Line, Professional and Leadership personnel.
- The Process Engineer must possess a high degree of initiative and flexibility, with the ability to react calmly and quickly in a rapidly changing environment and the ability to work independently.
- The Process Engineer would be required to do normal climbing, bending and lifting (at least 15 Kg) and therefore must be in good physical and mental health. Additionally the Process Engineer must have a normal sense of smell and be able to discern color.
- The Process Engineer must be capable of training and coordinating the activities of a diverse group of individuals, with varying levels of qualifications and experiences.
- The Process Engineer must be familiar with cGMP’s, particularly the ICH Q7A Guideline, Safety Standards, (particularly OSHA and DOT regulations) and the CPMP and GEP.