Overview
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in people who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main purpose of role
Responsible for project engineering aspects within PCI Pharma Services including:
Specification, development, purchase and introduction to site facility, production equipment tooling and processes in line with the companies and customers’ needs
Liaise with other departments and suppliers during the specification of new equipment to ensure fit for purpose is achieved.
Identification of future capital investment projects to improve the business offerings and competitive edge.
Raising of site capital application requests
To ensure that all engineering & technical projects are introduced successfully into the business, on time and in budget.
Primary responsibilities
Specification, development and purchase of site facility, equipment and tooling needs.
To ensure that all engineering & technical projects are introduced successfully into the business, on time and in budget.
Coordination and execution of Factory acceptance (FAT) and Site acceptance (SAT) trials.
Ensure the setup of all technical documentation and paperwork such as tooling logs, setting sheets, on line working sheets, planned preventative maintenance schedules, schedules covering all new equipment and plant brought onto site on the technical services department.
Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and technical standards, procedures and systems.
Ensuring that projects are achieved within the agreed timescale, cost and quality.
Maintenance of the technical operations and project engineering ways of working including but not limited to databases, specifications, templates, SOPs and training.
Maintenance of the site tooling capability databases and specifications.
Maintenance of the Technical Drawing database.
Producing Technical Drawings & Templates to support business & customer needs, this includes but is not limited to Tooling, Facility and Engineering drawings within the scope of the job-holder’s capabilities.
In conjunction with the operational group participate in Continuous Improvement Projects as required, including all OEE projects to ensure improved efficiencies, reduced waste and cost.
In conjunction the operational group assist in technical, product and process reviews to resolve operational, performance and functional issues.
Drive a Right First Time culture within operations to deliver a Zero Defect performance.
Deliver products of Value at Optimal Cost.
Monitoring of future technologies and market trends identifying areas for potential investment including reporting and recommendations to senior and executive members of the PCI Pharma Services group.
Build, develop and sustain the knowledge, capability and competency with the Technical Operations team to support ongoing and changing technologies employed to meet the business objectives.
Create and sustain a working environment that promotes the PCI Pharma Services Values and Behaviours.
Connect across PCI Pharma Services to drive performance.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
Scope and authority
The job holder is responsible for adhering to the company’s SOPs, Health & Safety, cGMP and other regulatory guidelines themselves and for team members and contractors under their supervision whilst operating on site PCI Pharma Services sites as well as offsite locations including but not limited to customers and suppliers addresses.
The job holder is responsible for managing and maintaining capital project budgets as and where appropriate.
This position has authority for expenditure as defined in the purchasing authority levels document.
Secondary responsibilities
Any other additional tasks that may be required by your Manager or any other person so appointed to act with such authority.
Requirements
Engineering degree - Level 7Trades QualificationOther suitable qualification
Essential
Previous office and operational based project engineering & packaging experience in a Pharmaceutical or FMCG business
Detailed understanding of facility and engineering issues and processes.
A flexible and willing attitude
Communication skills to interact with internal and external customers at a senior level.
Strong team player with open communication style with the ability to direct and train others and deliver clear instruction, including internal staff, suppliers, and tradesmen.
Ability to design and develop new equipment to help improve line effectiveness.
Ability to influence and collaborate at all levels in order to achieve company targets.
Ability to represent the company in a professional and highly competent manner.
Able to multitask and prioritise activities.
Ability to work on their own as well as part of a team.
Excellent problem-solving skills.
Dependable, reliable and shows good integrity.
Ability to travel on company business as required.
Desirable
Sound working knowledge of cGMP, 21CFR Part11, and GAMP “Current”.
Detailed understanding of blister pack tooling design and manufacturing processes.
Competent AutoCAD user with the ability to create and modify existing 2D drawings.
Packaging experience in a Pharmaceutical or FMCG business
Use of creating/amending PLC programs.
Use of engineering equipment such as lathes, milling machines, drilling machines and hand tools.
Equal Employment Opportunity (EEO) Statement
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
#J-18808-Ljbffr