Small Molecule Technical Lead - PQE Group : Job Details

We are a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With more than 2000 employees, 45+ nationalities and 40 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a multicultural and challenging company with many local and international projects, and colleagues from all over the world.

Due to a constant growth, we are looking for a Project Technical Lead - Small Molecule join our team and support upcoming projects in Indiana, IN.

Responsibilities include, but are not limited, to the following:

• Technical ownership for the Small Molecule project
• Technical management of the Small Molecule project system integrator
• Working closely with the Small Molecule Automation Project Manager to successfully deliver the project on schedule and budget
• Collaborate with Program technical offices to ensure the automation solution is aligned with the overall program automation philosophy and standards
• Collaborate with their Digital/MES work stream counterpart leads to align the automation and digital solutions
• Provide technical leadership to the multiple area leads working on their project for the respective area and ensure that applicable standards are followed
• Ensure consistency of the automation deliverables (requirements, functional specifications, control strategies, phases, and recipes, etc.)
• Participate in P&ID and control strategy reviews
• Assist in defining the software components that need to be created or modified
• Communicate progress, issues, and needs to automation project manager for the area
• Provide input, review, and approve functional requirements and specifications
• Support creation of Parameter and Recipe Specification documents
• Responding to system integrator technical queries
• Support the development of software testing strategies
• Identification of any remediation effort required on process control software
• Create items in the issue tracker as issues arise after the software acceptance
• Identify and analyze risks of technical nature particular to the area and planning responses
• Maintain compliance with training requirements

Our ideal candidate should have the following features:

• BS Engineering (or equivalent experience)
• 10+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing)
• Previous Small Molecule Manufacturing project or site experience
• Previous Pharmaceutical Automation Large Project/Program experience/expertise
• 7+ years' experience in DeltaV Batch DCS
• Preferable, a previous experience with Allen-Bradley PLCs
• Exceptional teamwork abilities
• Strong knowledge of GMP's, regulatory requirements and computer system validation principles
• Excellent written and verbal communication skills for both technical and non-technical audiences
• Strong knowledge of GMP's, regulatory requirements and computer system validation principles
• Excellent written and verbal communication skills for both technical and non-technical audiences

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview.

If there's a positive match, a technical interview with the Hiring Manager will be arranged.

In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal.

Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.