Job Information
PCI Pharma Services Project Engineer in Tredegar, United Kingdom
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:
Generation, review and approval of User Requirement Specifications.
Specification, development and purchase of equipment and facilities needs in conjunction with the engineering and other site functions.
To successfully plan, execute and deliver (including coordination and activity leadership of teams) several concurrent projects to agreed scope, and with necessary speed and urgency, whilst continuously monitoring changing priorities.
Responsible for technical solutions to enable the generation and approval of all new business quotations.
Responsible for the generation of MS Project Plan, manage internal departmental representatives, achieve milestones, and communicate the result across a stakeholder audience.
Responsible for the generation of Project Cost Tracking, manage financial expectations, achieve financial milestones, and communicate the result across a stakeholder audience.
Responsible for the execution of defined equipment trials and qualification activities.
Responsible for the execution of defined facility & utilities qualification.
Responsible for training relevant technicians and engineers in new and modified equipment and processes.
Main Responsibilities:
Ensure all activities undertaken are in accordance with statutory, regulatory and company EHS, cGMP and Engineering standards, procedures, and systems.
Development and maintenance of the materials, tooling and component specifications and ways of working including but not limited to databases, specifications, templates, SOP’s, and training.
Completion and support of IQ, OQ & PQ activities, and complete reports.
In conjunction with the Engineering group participate in Continuous Improvement Projects as required, including all OEE projects to ensure improved efficiencies, reduced waste, and cost.
Work alongside Site Project Team to support 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.
Drive a Right First-Time culture within operations to deliver a Zero Defect performance.
Deliver products of Value at Optimal Cost.
Work alongside Site Project Team to sustain the knowledge, capability, and competency with the Engineering & Operational team to support ongoing and changing technologies employed to meet the business objectives.
To comply with company policies, local, UK and global regulatory requirements including internal and external Health, Safety and Environmental standards at all times whilst completing tasks.
To comply with company policies, local, UK and global regulatory requirements including internal and external Health, Safety and Environmental standards at all times whilst completing tasks.
Assist in ensuring any items in the QMS are completed within the required timescale.
To identify self-development needs for future performance.
Provide training, support and direction to trainees / apprentices when required ensuring professional standards of workmanship and competence are achieved.
Maintaining close co-operation with all other departments to attain continual improvement in performance and standards of quality and reliability.
Dependant on knowledge and expertise, provide support when requested to other areas of the business upon the discretion of their department manager.
Maintain a degree of flexible working in order to support the business, when required, on weekends or after hours.
Training Level Specific Responsibilities
Project Engineer Level (3)
Fully trained in all aspects of Project Engineer Level 1 & 2
Educated to BTEC HND or degree level in a Technical, Engineering, Packaging or a Science subject with previous experience working in a technical role or equivalent industry level experience.
Proficient utilisation of software packages such as Excel, Word, PowerPoint, Project and Visio and a high level of computer literacy.
Detailed understanding of equipment & facility and engineering issues and processes.
Previous office and operational based packaging experience in a Pharmaceutical or FMCG business is essential.
Experience in Pharmaceutical Project Management. 3–5-year Project Engineer experience (inclusive of apprenticeship or equivalent)
Sound working knowledge of cGMP, 21CFR Part11, and GAMP “Current”.
Skills and Aptitudes:
A flexible and willing attitude is essential.
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.
Personal Qualities and Behaviours:
Be able to work as part of a team.
Ability to influence and collaborate at all levels to achieve company targets.
Be able to problem solve under high pressure situations.
Ability to represent the company in a professional and highly competent manner.
Has complete understanding of safety legislation, GMP and statutory requirements expected of them whilst carrying out engineering duties.
Competent AutoCAD user with the ability to create and modify existing 2D drawings.
A qualification in AutoCAD Design would be advantageous.
Regulatory/Industry Responsibilities:
The job holder is responsible for adhering to PCI SOPs, Health & Safety, GMP and other regulatory guidelines.
Attending external courses and / or reading current literature to keep “up to date” with current ideas / standards / legislation within the responsibility areas.
To assist in other duties as required by Senior Managers which are appropriate to the position.
Adhere to all site Health, Safety and Environment (HSE) working practices, and to ensure that all work related activities are conducted appropriately.
GMP Requirements Hierarchy:
GMP Skill Level 1 is essential for this role (further information regarding GMP Requirements Hierarchy, can be obtained at SOP-L&D-001
General Information:
Any deviation from this structure is to be approved by operations Director or General Manager
An Engineer may only be eligible to move up a level if their attitudes, behaviours and absenteeism meets expected standards and will be reviewed on a case-by-case basis.
The company reserves the right to demote a technician should they no longer exhibit the correct behaviours and attitudes that are required in the role.
An Engineer is responsible for ensuring the skills are maintained to a high standard.
The above is subject to regular review and potentially changes as required
Qualifications:
Educated to BTEC HND or degree level in a Technical, Engineering, Packaging, or a Science subject. Obtained previous experience working in a technical role or equivalent industry level experience.
A qualification in AutoCAD Design would be advantageous.
Experience:
- Not less than 2 years’ experience in Engineering within an allied industry.
#LI-MS1
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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, Diversity, Equity, and Inclusion (DEI) 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.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled