Compliance and Administration Engineer

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 all engineering internal and statutory compliance activities and administrative tasks at PCI Pharma Services, including providing technical solutions for timely closure of DRs and CCRs. The role involves using appropriate techniques to identify true root causes of incidents and implementing corrective actions to prevent recurrence. It ensures the maintenance of external statutory registers and supports both internal and external audits of the engineering group. Additionally, responsibilities include training technicians and engineers in root cause analysis tools, troubleshooting engineering and technical issues, and organising engineering documentation for audits.

Main responsibilities:

• Ensure all activities undertaken within the engineering departments are in accordance with statutory, regulatory and company EHS, cGMP and Engineering standards, procedures and systems.
• Ensuring any items in the QMS are completed within the required timescale
• Ensure the Engineering compliance metrics and KPIs are documented and acted upon for the engineering department.
• To ensure all audit findings are closed out in a timely manner.
• Tracking and logging of engineering work request forms relating to non-routine maintenance (breakdowns, general repairs, machine set up etc.)
• Liaise with external contractors and ensure all necessary documentation received from them are timely and acceptable.
• Co-ordinate between external contractors and departmental managers to arrange service visits and associated documentation.
• Ensuring engineering compliance documentation (technical agreements, service level contracts etc) are up to date and relevant for the equipment operating at PCI Tredegar. 
• To act as an administrator for the Planned Preventative Maintenance System (PPM), which is to include progress chasing of reports and external documents.
• Organising the effective storage and archiving of critical documents allowing prompt retrieval whilst ensuring security.
• Simplification and standardisation of all appropriate documentation.
• Identify and deliver cost savings to agreed targets.
• To identify self-development needs for future performance.
• 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.

Requirements

• Strong experience in Pharmaceutical packaging, manufacturing and utilities engineering.
• K knowledge of cGMP, 21CFR Part11, and GAMP “Current”.
• Knowledge of operational, commercial and technical aspects of site services.
• Previous experience in an office/administrative environment.
• Experience of lean manufacturing and investigational techniques e.g. root cause analysis
• Be able to work unsupervised to a high quality.
• Be able to complete paper work in accordance with RFI principles.
• Be competent in the use of Microsoft word and excel  
• Be able to work as part of a team.
• Be able to problem solve under high pressure situations.

Benefits

At PCI, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life. Here's what we offer:

• Employer Pension: Secure your future with our employer pension scheme (above statutory pension).

• Competitive Salaries: We offer competitive salaries that reflect your dedication and contributions.

• Generous Annual Leave: Enjoy 25 days of annual leave, plus bank holidays.

• Family Friendly Benefits: Enjoy a range of benefits designed to support your family life.

• Employee Referral Scheme: Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!

• Staff Engagement: We value your dedication with recognition schemes and long-service awards.

• Health and Well-being: Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.

• On-Site Subsidized Canteen.

• Cycle to Work Scheme.

• Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.